Trial Outcomes & Findings for Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy (MOMPOD) (NCT NCT02932475)

Last Updated: 2023-06-26

Results Overview

Participants with one or more of the following: * capillary blood glucose level of \< 30 mg/dL or capillary blood glucose requiring medical treatment, or * Birth trauma (umbilical cord artery pH \< 7.0 or shoulder dystocia with brachial plexus injury), or * Hyperbilirubinemia requiring phototherapy, or * Deliver \< 37 weeks' gestation, or * Miscarry, are stillborn, experience a neonatal demise, or * Large for gestational age infant (birth weight \> 90th percentile for gestational age), or * Small for gestational age infant (birth weight \< 10th percentile for gestational age) or low birth weight (\< 2500 gm)

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

831 participants

Primary outcome timeframe

An average of 48 hours for term infants and 30 days for preterm infants

Results posted on

2023-06-26

Participant Flow

Participant milestones

Participant milestones
Measure	Metformin Metformin 1000 mg twice a day	Placebo Placebo, identical to Metformin. Delivered to match active drug
Overall Study STARTED	416	415
Overall Study Randomized	416	415
Overall Study Received Intervention	397	397
Overall Study Liveborn Infants During Study	376	370
Overall Study COMPLETED	386	382
Overall Study NOT COMPLETED	30	33

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy (MOMPOD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Metformin n=397 Participants Metformin 1000 mg twice a day	Placebo n=397 Participants Placebo, identical to Metformin. Delivered to match active drug	Total n=794 Participants Total of all reporting groups
Age, Continuous	32.8 years STANDARD_DEVIATION 5.5 • n=5 Participants	33.1 years STANDARD_DEVIATION 5.7 • n=7 Participants	32.9 years STANDARD_DEVIATION 5.6 • n=5 Participants
Sex: Female, Male Female	397 Participants n=5 Participants	397 Participants n=7 Participants	794 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	203 Participants n=5 Participants	209 Participants n=7 Participants	412 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	183 Participants n=5 Participants	176 Participants n=7 Participants	359 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	116 Participants n=5 Participants	108 Participants n=7 Participants	224 Participants n=5 Participants
Race (NIH/OMB) White	55 Participants n=5 Participants	57 Participants n=7 Participants	112 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	226 Participants n=5 Participants	232 Participants n=7 Participants	458 Participants n=5 Participants
Region of Enrollment United States	397 Participants n=5 Participants	397 Participants n=7 Participants	794 Participants n=5 Participants

PRIMARY outcome

Timeframe: An average of 48 hours for term infants and 30 days for preterm infants

Population: Modified intent to treat population of all participants who took at least one dose of study agent and had primary outcome data available.

Outcome measures

Outcome measures
Measure	Metformin n=386 Participants Metformin 1000 mg twice a day	Placebo n=382 Participants Placebo, identical to Metformin. Delivered to match active drug
Number of Participants With Composite Adverse Neonatal Outcome	269 Participants	277 Participants

SECONDARY outcome

Timeframe: Throughout study until delivery at 40 weeks gestation

Secondary outcome of maternal side effects were defined as: * clinically relevant hypoglycemia defined as capillary blood glucose \< 60 or \< 80 with symptoms * GI side effects defined as nausea, vomiting, diarrhea

Outcome measures

Outcome measures
Measure	Metformin n=397 Participants Metformin 1000 mg twice a day	Placebo n=397 Participants Placebo, identical to Metformin. Delivered to match active drug
Number of Participants With Maternal Side Effects Clinically relevant hypoglycemia	87 Participants	85 Participants
Number of Participants With Maternal Side Effects Gastrointestinal side effects	182 Participants	171 Participants

SECONDARY outcome

Timeframe: Within 72 hrs of birth

Population: Data are reported for those infants who underwent anthropomorphic measurements.

Neonatal fat mass measured by skin-fold thickness (anthropometrics).The circumference of the upper limb is the circumference of the upper arm, and the circumference of the lower limb equals the mean of the circumferences measured at the midthigh and calf. The volume of the subcutaneous layer of fat covering each cylinder is estimated by multiplying the length times the circumference times the layer of fat estimated by the skinfold measures. The triceps skinfold measure is used as an estimate of the fat thickness of the limbs, and the subscapular skinfold measure approximates the fat thickness of the trunk. Total body fat is estimated by summing the volumes of fat covering each of the cylinders and multiplying by 0.9 (the density of fat).

Outcome measures

Outcome measures
Measure	Metformin n=218 Participants Metformin 1000 mg twice a day	Placebo n=219 Participants Placebo, identical to Metformin. Delivered to match active drug
Mean Infant Fat Mass	0.46 kg Standard Deviation 0.3	0.5 kg Standard Deviation 0.24

SECONDARY outcome

Timeframe: An average of 48 hours following delivery

Population: Number of randomized participants who took at least one dose of study agent.

Adverse maternal outcomes.

Outcome measures

Outcome measures
Measure	Metformin n=397 Participants Metformin 1000 mg twice a day	Placebo n=397 Participants Placebo, identical to Metformin. Delivered to match active drug
Maternal Safety Based on Treatment Emergent Adverse Events Any adverse event associated with fetal death	10 Participants	10 Participants
Maternal Safety Based on Treatment Emergent Adverse Events Any maternal serious adverse event	113 Participants	111 Participants
Maternal Safety Based on Treatment Emergent Adverse Events Any adverse event leading to early study agent discontinuation	13 Participants	20 Participants
Maternal Safety Based on Treatment Emergent Adverse Events Any adverse event associated with maternal death	2 Participants	1 Participants
Maternal Safety Based on Treatment Emergent Adverse Events Any maternal non-serious adverse event	149 Participants	157 Participants

SECONDARY outcome

Timeframe: up to 28 days of life

Adverse neonatal outcomes

Outcome measures

Outcome measures
Measure	Metformin n=376 Participants Metformin 1000 mg twice a day	Placebo n=370 Participants Placebo, identical to Metformin. Delivered to match active drug
Neonatal Safety Based on Treatment Emergent Adverse Events Any neonatal serious adverse event	81 Participants	105 Participants
Neonatal Safety Based on Treatment Emergent Adverse Events Any neonatal non-serious adverse event	157 Participants	162 Participants

Adverse Events

Maternal Metformin

Serious events: 113 serious events

Other events: 54 other events

Deaths: 2 deaths

Fetus of Mother Receiving Metformin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 10 deaths

Infants Born to Mothers Receiving Metformin

Serious events: 81 serious events

Other events: 151 other events

Deaths: 1 deaths

Maternal Placebo

Serious events: 111 serious events

Other events: 57 other events

Deaths: 1 deaths

Fetus of Mother Receiving Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 10 deaths

Infants Born to Mothers Receiving Placebo

Serious events: 105 serious events

Other events: 151 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Maternal Metformin n=397 participants at risk Metformin 1000 mg twice a day	Fetus of Mother Receiving Metformin n=397 participants at risk Fetuses in utero to mothers assigned metformin 1000 mg twice a day	Infants Born to Mothers Receiving Metformin n=376 participants at risk Infants born to mothers assigned metformin 1000 mg twice a day	Maternal Placebo n=397 participants at risk Placebo, identical to Metformin. Delivered to match active drug	Fetus of Mother Receiving Placebo n=397 participants at risk Fetuses in utero to mothers assigned placebo delivered to match active drug	Infants Born to Mothers Receiving Placebo n=370 participants at risk Infants born to mothers assigned placebo, identical to metformin, delivered to match active drug
Respiratory, thoracic and mediastinal disorders Surgical and medical procedures	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Reproductive system and breast disorders Cervix cerclage procedure	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Vascular disorders Hypertension	1.8% 7/397 • Number of events 7 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.27% 1/376 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	1.8% 7/397 • Number of events 7 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Blood and lymphatic system disorders Anemia	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Cardiac disorders Cardiac arrest	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Cardiac disorders Cardiac Failure Congestive	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Cardiac disorders Pulmonary Edema	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Cardiac disorders Chest Pain'	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Gastrointestinal disorders Hyperemesis	0.76% 3/397 • Number of events 3 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.76% 3/397 • Number of events 3 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Gastrointestinal disorders Abdominal Pain	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Gastrointestinal disorders Constipation	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Gastrointestinal disorders Gastroenteritis	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Gastrointestinal disorders Pancreatitis	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Hepatobiliary disorders HELLP Syndrome	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.50% 2/397 • Number of events 2 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Immune system disorders Asthma	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Infections and infestations Pyelonephritis	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	1.0% 4/397 • Number of events 4 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Infections and infestations Pneumonia	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.76% 3/397 • Number of events 3 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Infections and infestations Postop wound infection	0.50% 2/397 • Number of events 2 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Infections and infestations Abscess	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Infections and infestations Amniotic cavity infection	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Infections and infestations Sepsis	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Infections and infestations Viral infection	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Infections and infestations Wound infection	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Injury, poisoning and procedural complications Postop wound complication	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Injury, poisoning and procedural complications Road traffic accident	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Injury, poisoning and procedural complications Fall	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Metabolism and nutrition disorders Hyperglycemia	2.3% 9/397 • Number of events 9 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	1.8% 7/397 • Number of events 7 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.76% 3/397 • Number of events 3 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Metabolism and nutrition disorders Adrenal insufficiency	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Metabolism and nutrition disorders Hypoglycaemia	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	2.1% 8/376 • Number of events 8 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.50% 2/397 • Number of events 2 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	3.5% 13/370 • Number of events 13 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Metabolism and nutrition disorders Gastroparesis	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Musculoskeletal and connective tissue disorders Osteomyelitis	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Nervous system disorders Headache	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.50% 2/397 • Number of events 2 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Nervous system disorders Thrombotic stroke	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Pregnancy, puerperium and perinatal conditions Preeclampsia	11.1% 44/397 • Number of events 44 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	8.1% 32/397 • Number of events 32 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.27% 1/370 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Pregnancy, puerperium and perinatal conditions Gestational hypertension	1.0% 4/397 • Number of events 4 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	1.0% 4/397 • Number of events 4 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Pregnancy, puerperium and perinatal conditions Preterm premature rupture of membranes	0.50% 2/397 • Number of events 2 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	1.0% 4/397 • Number of events 4 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Pregnancy, puerperium and perinatal conditions Preterm labour	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	1.0% 4/397 • Number of events 4 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Pregnancy, puerperium and perinatal conditions Oligohydramnios	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Pregnancy, puerperium and perinatal conditions Postpartum hemorrhage	0.50% 2/397 • Number of events 2 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Pregnancy, puerperium and perinatal conditions Preterm delivery	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	5.1% 19/376 • Number of events 19 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.50% 2/397 • Number of events 2 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	5.9% 22/370 • Number of events 22 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Pregnancy, puerperium and perinatal conditions Foetal growth restriction	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Pregnancy, puerperium and perinatal conditions Placenta praevia haemorrhage	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Psychiatric disorders Bipolar disorder	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Psychiatric disorders Depression	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Psychiatric disorders Psychotic disorder	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Renal and urinary disorders Urinary tract infection	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Reproductive system and breast disorders Endometritis	0.76% 3/397 • Number of events 3 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Reproductive system and breast disorders Puerperal infection	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Reproductive system and breast disorders Shortened cervix	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Reproductive system and breast disorders Vaginal infection	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.50% 2/397 • Number of events 2 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Respiratory, thoracic and mediastinal disorders Influenza	0.50% 2/397 • Number of events 2 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Respiratory, thoracic and mediastinal disorders COVID-19	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Respiratory, thoracic and mediastinal disorders Social circumstances	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Respiratory, thoracic and mediastinal disorders Homeless	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Vascular disorders Hypertensive emergency	1.0% 4/397 • Number of events 4 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.50% 2/397 • Number of events 2 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Vascular disorders Vaginal haemorrhage	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.50% 2/397 • Number of events 2 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Vascular disorders Myocardial infarction	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Vascular disorders Placental insufficiency	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Vascular disorders Pulmonary embolism	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Blood and lymphatic system disorders Haemolysis neonatal	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.27% 1/376 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Cardiac disorders Nonreassuring foetal heart rate pattern	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.53% 2/376 • Number of events 2 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Congenital, familial and genetic disorders Ventricular septal defect	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	1.1% 4/376 • Number of events 4 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.27% 1/370 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Congenital, familial and genetic disorders Persistent foetal circulation	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.53% 2/376 • Number of events 2 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.54% 2/370 • Number of events 2 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Congenital, familial and genetic disorders Atrial septal defect	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.27% 1/376 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.27% 1/370 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Congenital, familial and genetic disorders Fallot's tetralogy	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.54% 2/370 • Number of events 2 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Congenital, familial and genetic disorders Cardiac septal defect	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.27% 1/376 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Congenital, familial and genetic disorders Laryngomalacia	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.27% 1/376 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Congenital, familial and genetic disorders Truncus arteriosus persistent	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.27% 1/376 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Gastrointestinal disorders Anal atresia	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.27% 1/376 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.27% 1/370 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Gastrointestinal disorders Necrotising colitis	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.27% 1/376 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.27% 1/370 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Gastrointestinal disorders Beckwith-Wiedemann syndrome	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.27% 1/376 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.27% 1/376 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.27% 1/370 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Metabolism and nutrition disorders Hyperbilirubinaemia neonatal	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.27% 1/376 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.81% 3/370 • Number of events 3 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.27% 1/370 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Vascular disorders Pulmonary hypertension	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.27% 1/370 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Skin and subcutaneous tissue disorders Jaundice	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.27% 1/376 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	1.9% 7/370 • Number of events 7 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	1.1% 4/376 • Number of events 4 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	2.4% 9/370 • Number of events 9 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Respiratory, thoracic and mediastinal disorders Pulmonary malformation	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.27% 1/376 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Reproductive system and breast disorders Pulmonary sequestration	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.27% 1/370 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Reproductive system and breast disorders Neonatal testicular torsion	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.27% 1/370 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Reproductive system and breast disorders Genitalia external ambiguous	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.27% 1/376 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Pregnancy, puerperium and perinatal conditions Small for dates baby	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.27% 1/376 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Pregnancy, puerperium and perinatal conditions Infantile apnoea	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.27% 1/370 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Pregnancy, puerperium and perinatal conditions Hydrops foetalis	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.27% 1/376 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.27% 1/370 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Respiratory, thoracic and mediastinal disorders Neonatal respiratory failure	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.80% 3/376 • Number of events 3 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	1.4% 5/370 • Number of events 5 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Pregnancy, puerperium and perinatal conditions Immature respiratory system	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	1.1% 4/376 • Number of events 4 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	2.2% 8/370 • Number of events 8 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Pregnancy, puerperium and perinatal conditions Premature delivery	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	5.1% 19/376 • Number of events 19 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	5.9% 22/370 • Number of events 22 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.

Other adverse events

Other adverse events
Measure	Maternal Metformin n=397 participants at risk Metformin 1000 mg twice a day	Fetus of Mother Receiving Metformin n=397 participants at risk Fetuses in utero to mothers assigned metformin 1000 mg twice a day	Infants Born to Mothers Receiving Metformin n=376 participants at risk Infants born to mothers assigned metformin 1000 mg twice a day	Maternal Placebo n=397 participants at risk Placebo, identical to Metformin. Delivered to match active drug	Fetus of Mother Receiving Placebo n=397 participants at risk Fetuses in utero to mothers assigned placebo delivered to match active drug	Infants Born to Mothers Receiving Placebo n=370 participants at risk Infants born to mothers assigned placebo, identical to metformin, delivered to match active drug
Gastrointestinal disorders Abdominal pain	5.8% 23/397 • Number of events 23 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	5.0% 20/397 • Number of events 20 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Nervous system disorders Headache	7.8% 31/397 • Number of events 31 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/376 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	9.1% 36/397 • Number of events 36 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/370 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	14.9% 56/376 • Number of events 56 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.25% 1/397 • Number of events 1 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	14.6% 54/370 • Number of events 54 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.
Skin and subcutaneous tissue disorders Jaundice	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	25.3% 95/376 • Number of events 95 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	0.00% 0/397 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.	26.2% 97/370 • Number of events 97 • For mothers, AEs were collected from time of randomization to time of hospital discharge after delivery, an average of 48 hours following delivery. For infants, from birth through 28 days of age.

Additional Information

Kim Boggess, MD

University of North Carolina at Chapel Hill

Phone: 919-966-1601

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place