Trial Outcomes & Findings for PREGNANT Short Cervix Trial (NCT NCT00615550)
NCT ID: NCT00615550
Last Updated: 2012-03-13
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
465 participants
Primary outcome timeframe
9 to 13 weeks
Results posted on
2012-03-13
Participant Flow
March 2008 to June 2010
Participant milestones
| Measure |
Placebo
placebo vaginal gel
|
Prochieve
Progesterone 8% Vaginal Gel
|
|---|---|---|
|
Overall Study
STARTED
|
229
|
236
|
|
Overall Study
COMPLETED
|
223
|
235
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
Reasons for withdrawal
| Measure |
Placebo
placebo vaginal gel
|
Prochieve
Progesterone 8% Vaginal Gel
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
1
|
Baseline Characteristics
PREGNANT Short Cervix Trial
Baseline characteristics by cohort
| Measure |
Placebo
n=223 Participants
placebo vaginal gel
|
Prochieve
n=235 Participants
Progesterone 8% Vaginal Gel
|
Total
n=458 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
223 Participants
n=5 Participants
|
235 Participants
n=7 Participants
|
458 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
26.2 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
26.5 years
STANDARD_DEVIATION 5.8 • n=7 Participants
|
26.4 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
223 Participants
n=5 Participants
|
235 Participants
n=7 Participants
|
458 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Belarus
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=5 Participants
|
107 participants
n=7 Participants
|
207 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
26 participants
n=5 Participants
|
28 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Chile
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
India
|
73 participants
n=5 Participants
|
73 participants
n=7 Participants
|
146 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 to 13 weeksPopulation: Intent to Treat
Outcome measures
| Measure |
Placebo
n=223 Participants
placebo vaginal gel
|
Prochieve
n=235 Participants
Progesterone 8% Vaginal Gel
|
|---|---|---|
|
Number of Participants With Birth <=32 6/7 Weeks Gestation.
|
36 participants
|
21 participants
|
SECONDARY outcome
Timeframe: Delivery Hospitalization (1-212 days)Each infant is scored based on the 7 morbidity and mortality events above: 0= no morbidity event 1. 1 morbidity event 2. 2 morbidity events 3. 3 or more morbidity events 4. mortality
Outcome measures
| Measure |
Placebo
n=223 Participants
placebo vaginal gel
|
Prochieve
n=235 Participants
Progesterone 8% Vaginal Gel
|
|---|---|---|
|
Number of Infants With Neonatal Morbidities Such as Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Intraventricular Hemorrhage (IVH), Proven Sepsis, and Necrotizing Enterocolitis (NEC)
Composite score 0
|
192 participants
|
217 participants
|
|
Number of Infants With Neonatal Morbidities Such as Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Intraventricular Hemorrhage (IVH), Proven Sepsis, and Necrotizing Enterocolitis (NEC)
Composite score 1
|
11 participants
|
5 participants
|
|
Number of Infants With Neonatal Morbidities Such as Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Intraventricular Hemorrhage (IVH), Proven Sepsis, and Necrotizing Enterocolitis (NEC)
Composite score 2
|
8 participants
|
2 participants
|
|
Number of Infants With Neonatal Morbidities Such as Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Intraventricular Hemorrhage (IVH), Proven Sepsis, and Necrotizing Enterocolitis (NEC)
Composite score 3
|
0 participants
|
3 participants
|
|
Number of Infants With Neonatal Morbidities Such as Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Intraventricular Hemorrhage (IVH), Proven Sepsis, and Necrotizing Enterocolitis (NEC)
Composite score 4
|
11 participants
|
8 participants
|
|
Number of Infants With Neonatal Morbidities Such as Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Intraventricular Hemorrhage (IVH), Proven Sepsis, and Necrotizing Enterocolitis (NEC)
Infants with RDS
|
17 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Gestational Age at DeliveryPopulation: Intent to Treat
Number of participants at \<=27 6/7 , \<=34 6/7, and \<36 6/7.
Outcome measures
| Measure |
Placebo
n=223 Participants
placebo vaginal gel
|
Prochieve
n=235 Participants
Progesterone 8% Vaginal Gel
|
|---|---|---|
|
Number of Subjects With Preterm Birth at ≤27 6/7, ≤34 6/7, and <36 6/7 Weeks Gestation.
Number of deliveries <= 27 6/7 weeks
|
23 participants
|
12 participants
|
|
Number of Subjects With Preterm Birth at ≤27 6/7, ≤34 6/7, and <36 6/7 Weeks Gestation.
Number of deliveries <= 34 6/7 weeks
|
52 participants
|
34 participants
|
|
Number of Subjects With Preterm Birth at ≤27 6/7, ≤34 6/7, and <36 6/7 Weeks Gestation.
Number of deliveries <= 36 weeks
|
76 participants
|
71 participants
|
SECONDARY outcome
Timeframe: Delivery to 28 daysPopulation: All infants with a known delivery date and status.
Outcome measures
| Measure |
Placebo
n=223 Participants
placebo vaginal gel
|
Prochieve
n=235 Participants
Progesterone 8% Vaginal Gel
|
|---|---|---|
|
Number of Neonates Who Died.
|
5 participants
|
3 participants
|
SECONDARY outcome
Timeframe: date of deliveryPopulation: Available birth weight.
Assessment of birth weight \< 1500 grams or \< 2500 grams
Outcome measures
| Measure |
Placebo
n=220 Participants
placebo vaginal gel
|
Prochieve
n=234 Participants
Progesterone 8% Vaginal Gel
|
|---|---|---|
|
Number of Infants With a Birth Weight < 1500 Grams or < 2500 Grams
Birth weight < 1500 grams
|
30 participants
|
15 participants
|
|
Number of Infants With a Birth Weight < 1500 Grams or < 2500 Grams
Birth weight < 2500 grams
|
68 participants
|
60 participants
|
Adverse Events
Placebo
Serious events: 98 serious events
Other events: 24 other events
Deaths: 0 deaths
Prochieve
Serious events: 97 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=223 participants at risk；n=224 participants at risk
placebo vaginal gel
|
Prochieve
n=235 participants at risk
Progesterone 8% Vaginal Gel
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
premature baby
|
20.5%
46/224 • Number of events 46 • Randomization to delivery (1 day to 168 days)
|
18.7%
44/235 • Number of events 44 • Randomization to delivery (1 day to 168 days)
|
|
Pregnancy, puerperium and perinatal conditions
premature labor
|
14.7%
33/224 • Number of events 33 • Randomization to delivery (1 day to 168 days)
|
7.2%
17/235 • Number of events 17 • Randomization to delivery (1 day to 168 days)
|
|
Pregnancy, puerperium and perinatal conditions
premature rupture of the membranes
|
4.0%
9/224 • Number of events 9 • Randomization to delivery (1 day to 168 days)
|
5.1%
12/235 • Number of events 12 • Randomization to delivery (1 day to 168 days)
|
|
Reproductive system and breast disorders
cervix disorder
|
5.4%
12/224 • Number of events 12 • Randomization to delivery (1 day to 168 days)
|
8.9%
21/235 • Number of events 21 • Randomization to delivery (1 day to 168 days)
|
|
Pregnancy, puerperium and perinatal conditions
uterine contractions abnormal
|
3.1%
7/224 • Number of events 7 • Randomization to delivery (1 day to 168 days)
|
2.1%
5/235 • Number of events 5 • Randomization to delivery (1 day to 168 days)
|
|
Pregnancy, puerperium and perinatal conditions
foetal distress abnormal
|
1.3%
3/224 • Number of events 3 • Randomization to delivery (1 day to 168 days)
|
2.6%
6/235 • Number of events 6 • Randomization to delivery (1 day to 168 days)
|
|
Pregnancy, puerperium and perinatal conditions
cervical incompetence
|
1.3%
3/224 • Number of events 3 • Randomization to delivery (1 day to 168 days)
|
1.7%
4/235 • Number of events 4 • Randomization to delivery (1 day to 168 days)
|
|
Pregnancy, puerperium and perinatal conditions
pre-eclampsia
|
1.8%
4/224 • Number of events 4 • Randomization to delivery (1 day to 168 days)
|
0.85%
2/235 • Number of events 2 • Randomization to delivery (1 day to 168 days)
|
|
Pregnancy, puerperium and perinatal conditions
stillbirth
|
1.3%
3/224 • Number of events 3 • Randomization to delivery (1 day to 168 days)
|
1.3%
3/235 • Number of events 3 • Randomization to delivery (1 day to 168 days)
|
|
Pregnancy, puerperium and perinatal conditions
chorioamnionitis
|
1.3%
3/224 • Number of events 3 • Randomization to delivery (1 day to 168 days)
|
0.85%
2/235 • Number of events 2 • Randomization to delivery (1 day to 168 days)
|
|
Pregnancy, puerperium and perinatal conditions
foetal growth retardation
|
1.8%
4/224 • Number of events 4 • Randomization to delivery (1 day to 168 days)
|
0.43%
1/235 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
|
Pregnancy, puerperium and perinatal conditions
pregnancy induced hypertension
|
0.45%
1/224 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
1.7%
4/235 • Number of events 4 • Randomization to delivery (1 day to 168 days)
|
|
Pregnancy, puerperium and perinatal conditions
premature separation of placenta
|
1.8%
4/224 • Number of events 4 • Randomization to delivery (1 day to 168 days)
|
0.43%
1/235 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
|
Pregnancy, puerperium and perinatal conditions
foetal heart rate deceleration
|
0.89%
2/224 • Number of events 2 • Randomization to delivery (1 day to 168 days)
|
0.85%
2/235 • Number of events 2 • Randomization to delivery (1 day to 168 days)
|
|
Pregnancy, puerperium and perinatal conditions
intra-uterine death
|
0.89%
2/224 • Number of events 2 • Randomization to delivery (1 day to 168 days)
|
0.85%
2/235 • Number of events 2 • Randomization to delivery (1 day to 168 days)
|
|
Pregnancy, puerperium and perinatal conditions
funisitis
|
0.89%
2/224 • Number of events 2 • Randomization to delivery (1 day to 168 days)
|
0.43%
1/235 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
|
Pregnancy, puerperium and perinatal conditions
oligohydramnios
|
0.45%
1/224 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
0.85%
2/235 • Number of events 2 • Randomization to delivery (1 day to 168 days)
|
|
Pregnancy, puerperium and perinatal conditions
HELLP syndrome
|
0.45%
1/224 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
0.43%
1/235 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
|
Pregnancy, puerperium and perinatal conditions
postpartum haemorrhage
|
0.89%
2/224 • Number of events 2 • Randomization to delivery (1 day to 168 days)
|
0.00%
0/235 • Randomization to delivery (1 day to 168 days)
|
|
Pregnancy, puerperium and perinatal conditions
bradycardia foetal
|
0.45%
1/224 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
0.00%
0/235 • Randomization to delivery (1 day to 168 days)
|
|
Pregnancy, puerperium and perinatal conditions
breech presentation
|
0.45%
1/224 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
0.00%
0/235 • Randomization to delivery (1 day to 168 days)
|
|
Pregnancy, puerperium and perinatal conditions
cholestasis of pregnancy
|
0.00%
0/224 • Randomization to delivery (1 day to 168 days)
|
0.43%
1/235 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
|
Pregnancy, puerperium and perinatal conditions
eclampsia
|
0.45%
1/224 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
0.00%
0/235 • Randomization to delivery (1 day to 168 days)
|
|
Pregnancy, puerperium and perinatal conditions
foetal movements decreased
|
0.45%
1/224 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
0.00%
0/235 • Randomization to delivery (1 day to 168 days)
|
|
Pregnancy, puerperium and perinatal conditions
obstructed labour
|
0.00%
0/224 • Randomization to delivery (1 day to 168 days)
|
0.43%
1/235 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
|
Pregnancy, puerperium and perinatal conditions
placenta accreta
|
0.00%
0/224 • Randomization to delivery (1 day to 168 days)
|
0.43%
1/235 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
|
Pregnancy, puerperium and perinatal conditions
tachycardia foetal
|
0.45%
1/224 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
0.00%
0/235 • Randomization to delivery (1 day to 168 days)
|
|
Pregnancy, puerperium and perinatal conditions
umbilical cord prolapse
|
0.45%
1/224 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
0.00%
0/235 • Randomization to delivery (1 day to 168 days)
|
|
Pregnancy, puerperium and perinatal conditions
vomiting in pregnancy
|
0.45%
1/224 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
0.00%
0/235 • Randomization to delivery (1 day to 168 days)
|
|
Reproductive system and breast disorders
uterine pain
|
0.45%
1/224 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
0.00%
0/235 • Randomization to delivery (1 day to 168 days)
|
|
Reproductive system and breast disorders
vaginal discharge
|
0.00%
0/224 • Randomization to delivery (1 day to 168 days)
|
0.43%
1/235 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
|
Surgical and medical procedures
cervix cerclage procedure
|
2.2%
5/224 • Number of events 5 • Randomization to delivery (1 day to 168 days)
|
3.8%
9/235 • Number of events 9 • Randomization to delivery (1 day to 168 days)
|
|
Surgical and medical procedures
maternal therapy to enhance foetal lung maturity
|
0.45%
1/224 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
0.43%
1/235 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
|
Gastrointestinal disorders
abdominal pain lower
|
0.89%
2/224 • Number of events 2 • Randomization to delivery (1 day to 168 days)
|
0.85%
2/235 • Number of events 2 • Randomization to delivery (1 day to 168 days)
|
|
Gastrointestinal disorders
abdominal pain
|
0.45%
1/224 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
0.85%
2/235 • Number of events 2 • Randomization to delivery (1 day to 168 days)
|
|
Gastrointestinal disorders
nausea
|
0.45%
1/224 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
0.43%
1/235 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
|
Gastrointestinal disorders
diarrhoea
|
0.45%
1/224 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
0.00%
0/235 • Randomization to delivery (1 day to 168 days)
|
|
Gastrointestinal disorders
gastritis
|
0.00%
0/224 • Randomization to delivery (1 day to 168 days)
|
0.43%
1/235 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/224 • Randomization to delivery (1 day to 168 days)
|
0.43%
1/235 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
|
Infections and infestations
upper respiratory tract infection
|
0.89%
2/224 • Number of events 2 • Randomization to delivery (1 day to 168 days)
|
0.85%
2/235 • Number of events 2 • Randomization to delivery (1 day to 168 days)
|
|
Infections and infestations
cytomegalovirus infection
|
0.45%
1/224 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
0.00%
0/235 • Randomization to delivery (1 day to 168 days)
|
|
Infections and infestations
pneumonia
|
0.00%
0/224 • Randomization to delivery (1 day to 168 days)
|
0.43%
1/235 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
|
Infections and infestations
ureaplasma infection
|
0.00%
0/224 • Randomization to delivery (1 day to 168 days)
|
0.43%
1/235 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
|
Infections and infestations
urinary tract infection
|
0.45%
1/224 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
0.00%
0/235 • Randomization to delivery (1 day to 168 days)
|
|
Injury, poisoning and procedural complications
fall
|
0.45%
1/224 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
0.85%
2/235 • Number of events 2 • Randomization to delivery (1 day to 168 days)
|
|
Injury, poisoning and procedural complications
abdominal injury
|
0.00%
0/224 • Randomization to delivery (1 day to 168 days)
|
0.43%
1/235 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
|
Blood and lymphatic system disorders
anemia
|
0.45%
1/224 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
0.43%
1/235 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
|
General disorders
pyrexia
|
0.89%
2/224 • Number of events 2 • Randomization to delivery (1 day to 168 days)
|
0.00%
0/235 • Randomization to delivery (1 day to 168 days)
|
|
Hepatobiliary disorders
cholecysitis acute
|
0.00%
0/224 • Randomization to delivery (1 day to 168 days)
|
0.43%
1/235 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
|
Hepatobiliary disorders
gallbladder disorder
|
0.45%
1/224 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
0.00%
0/235 • Randomization to delivery (1 day to 168 days)
|
|
Cardiac disorders
atrial fibrillation
|
0.45%
1/224 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
0.00%
0/235 • Randomization to delivery (1 day to 168 days)
|
|
Immune system disorders
hypersensitivity
|
0.45%
1/224 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
0.00%
0/235 • Randomization to delivery (1 day to 168 days)
|
|
Investigations
feotal monitoring
|
0.00%
0/224 • Randomization to delivery (1 day to 168 days)
|
0.43%
1/235 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
|
Metabolism and nutrition disorders
gestational diabetes
|
0.45%
1/224 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
0.00%
0/235 • Randomization to delivery (1 day to 168 days)
|
|
Renal and urinary disorders
hydronephrosis
|
0.45%
1/224 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
0.00%
0/235 • Randomization to delivery (1 day to 168 days)
|
|
Social circumstances
physical assault
|
0.00%
0/224 • Randomization to delivery (1 day to 168 days)
|
0.43%
1/235 • Number of events 1 • Randomization to delivery (1 day to 168 days)
|
Other adverse events
| Measure |
Placebo
n=223 participants at risk；n=224 participants at risk
placebo vaginal gel
|
Prochieve
n=235 participants at risk
Progesterone 8% Vaginal Gel
|
|---|---|---|
|
Gastrointestinal disorders
abdominal pain
|
4.9%
11/223 • Number of events 11 • Randomization to delivery (1 day to 168 days)
|
5.5%
13/235 • Number of events 13 • Randomization to delivery (1 day to 168 days)
|
|
Gastrointestinal disorders
Dyspepsia
|
5.4%
12/223 • Number of events 12 • Randomization to delivery (1 day to 168 days)
|
6.4%
15/235 • Number of events 15 • Randomization to delivery (1 day to 168 days)
|
|
Gastrointestinal disorders
Nausea
|
10.3%
23/223 • Number of events 23 • Randomization to delivery (1 day to 168 days)
|
9.8%
23/235 • Number of events 23 • Randomization to delivery (1 day to 168 days)
|
|
Infections and infestations
Vaginitis bacterial
|
2.7%
6/223 • Number of events 6 • Randomization to delivery (1 day to 168 days)
|
5.1%
12/235 • Number of events 12 • Randomization to delivery (1 day to 168 days)
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
4.9%
11/223 • Number of events 11 • Randomization to delivery (1 day to 168 days)
|
7.2%
17/235 • Number of events 17 • Randomization to delivery (1 day to 168 days)
|
|
Nervous system disorders
Headache
|
8.1%
18/223 • Number of events 18 • Randomization to delivery (1 day to 168 days)
|
6.8%
16/235 • Number of events 16 • Randomization to delivery (1 day to 168 days)
|
|
Pregnancy, puerperium and perinatal conditions
Bleeding peripartum
|
6.3%
14/223 • Number of events 14 • Randomization to delivery (1 day to 168 days)
|
3.8%
9/235 • Number of events 9 • Randomization to delivery (1 day to 168 days)
|
|
Pregnancy, puerperium and perinatal conditions
Vomiting in pregnancy
|
5.4%
12/223 • Number of events 12 • Randomization to delivery (1 day to 168 days)
|
4.3%
10/235 • Number of events 10 • Randomization to delivery (1 day to 168 days)
|
|
Reproductive system and breast disorders
Vaginal infection
|
4.9%
11/223 • Number of events 11 • Randomization to delivery (1 day to 168 days)
|
6.4%
15/235 • Number of events 15 • Randomization to delivery (1 day to 168 days)
|
|
Reproductive system and breast disorders
cervix disorder
|
7.6%
17/223 • Number of events 17 • Randomization to delivery (1 day to 168 days)
|
9.8%
23/235 • Number of events 23 • Randomization to delivery (1 day to 168 days)
|
|
Blood and lymphatic system disorders
anaemia
|
6.3%
14/223 • Number of events 14 • Randomization to delivery (1 day to 168 days)
|
6.4%
15/235 • Number of events 15 • Randomization to delivery (1 day to 168 days)
|
|
Pregnancy, puerperium and perinatal conditions
chorioamnionitis
|
5.4%
12/223 • Number of events 12 • Randomization to delivery (1 day to 168 days)
|
5.1%
12/235 • Number of events 12 • Randomization to delivery (1 day to 168 days)
|
|
Musculoskeletal and connective tissue disorders
back pain
|
4.9%
11/223 • Number of events 11 • Randomization to delivery (1 day to 168 days)
|
5.1%
12/235 • Number of events 12 • Randomization to delivery (1 day to 168 days)
|
|
Metabolism and nutrition disorders
gestational diabetes
|
4.0%
9/223 • Number of events 9 • Randomization to delivery (1 day to 168 days)
|
6.0%
14/235 • Number of events 14 • Randomization to delivery (1 day to 168 days)
|
|
Pregnancy, puerperium and perinatal conditions
premature rupture of membranes
|
4.5%
10/223 • Number of events 10 • Randomization to delivery (1 day to 168 days)
|
5.5%
13/235 • Number of events 13 • Randomization to delivery (1 day to 168 days)
|
|
Infections and infestations
urinary tract infection
|
4.0%
9/223 • Number of events 9 • Randomization to delivery (1 day to 168 days)
|
4.7%
11/235 • Number of events 11 • Randomization to delivery (1 day to 168 days)
|
|
Pregnancy, puerperium and perinatal conditions
foetal growth retardation
|
4.9%
11/223 • Number of events 11 • Randomization to delivery (1 day to 168 days)
|
2.1%
5/235 • Number of events 5 • Randomization to delivery (1 day to 168 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place