Trial Outcomes & Findings for Improving Pregnancy Outcomes With Progesterone (NCT NCT03297216)

NCT ID: NCT03297216

Last Updated: 2021-07-22

Results Overview

A composite of live births prior to 37 weeks of gestation or stillbirth occurring at any gestational age

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 800 participants
• Primary outcome timeframe: At delivery, up to 37 weeks of gestation for live births and up to approximately 40 weeks of gestation for stillbirths
• Results posted on: 2021-07-22

Participant Flow

Participant milestones

Measure	250 mg 17P The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. 17P: Synthetic progestin	Placebo The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. Placebo: Non-active placebo comparator
Overall Study STARTED	399	401
Overall Study Discontinued Intervention	5	4
Overall Study Infants Born During Study	399	401
Overall Study COMPLETED	396	396
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Measure	250 mg 17P The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. 17P: Synthetic progestin	Placebo The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. Placebo: Non-active placebo comparator
Overall Study Death	0	1
Overall Study Miscarriage	0	2
Overall Study Lost to Follow-up	3	2

Baseline Characteristics

Improving Pregnancy Outcomes With Progesterone

Baseline characteristics by cohort

Measure	Mothers: 250 mg 17P n=399 Participants Mothers started study intervention between 16-24 weeks gestation and were administered weekly injections thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner. Participants followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. 17P: Synthetic progestin	Mothers: Placebo n=401 Participants Mothers started study intervention between 16-24 weeks gestation and were administered weekly injections thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner. Participants followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. Placebo: Non-active placebo comparator	Total n=800 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	399 Participants n=5 Participants	401 Participants n=7 Participants	800 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	29 years n=5 Participants	30 years n=7 Participants	29 years n=5 Participants
Sex: Female, Male Female	399 Participants n=5 Participants	401 Participants n=7 Participants	800 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	399 Participants n=5 Participants	401 Participants n=7 Participants	800 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	399 Participants n=5 Participants	401 Participants n=7 Participants	800 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Zambia	399 Participants n=5 Participants	401 Participants n=7 Participants	800 Participants n=5 Participants

PRIMARY outcome

Timeframe: At delivery, up to 37 weeks of gestation for live births and up to approximately 40 weeks of gestation for stillbirths

Population: Participants who received at least one injection of study product

A composite of live births prior to 37 weeks of gestation or stillbirth occurring at any gestational age

Outcome measures

Measure	250 mg 17P n=399 Participants The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. 17P: Synthetic progestin	Placebo n=401 Participants The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. Placebo: Non-active placebo comparator
Number of Participants Experiencing Preterm Births or Stillbirths	36 Participants	36 Participants

SECONDARY outcome

Timeframe: At delivery, up to 37 weeks of gestation

Population: Participants who received at least one injection of study product

Delivery prior to 37 gestational weeks

Outcome measures

Measure	250 mg 17P n=399 Participants The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. 17P: Synthetic progestin	Placebo n=401 Participants The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. Placebo: Non-active placebo comparator
Number of Participants Experiencing Preterm Birth <37 Weeks	31 Participants	35 Participants

SECONDARY outcome

Timeframe: At delivery, up to 34 weeks of gestation

Population: Participants who received at least one injection of study product

Delivery prior to 34 gestational weeks

Outcome measures

Measure	250 mg 17P n=399 Participants The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. 17P: Synthetic progestin	Placebo n=401 Participants The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. Placebo: Non-active placebo comparator
Number of Participants Experiencing Preterm Birth <34 Weeks	14 Participants	16 Participants

SECONDARY outcome

Timeframe: At delivery, up to 28 weeks of gestation

Population: Participants who received at least one injection of study product

Delivery prior to 28 gestational weeks

Outcome measures

Measure	250 mg 17P n=399 Participants The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. 17P: Synthetic progestin	Placebo n=401 Participants The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. Placebo: Non-active placebo comparator
Number of Participants Experiencing Preterm Birth <28 Weeks	3 Participants	5 Participants

SECONDARY outcome

Timeframe: At delivery, up to approximately 40 weeks of gestation

Population: Participants who received at least one injection of study product

Participants who had a fetus born without signs of life at any gestational age

Outcome measures

Measure	250 mg 17P n=399 Participants The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. 17P: Synthetic progestin	Placebo n=401 Participants The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. Placebo: Non-active placebo comparator
Number of Participants Experiencing Stillbirth	10 Participants	11 Participants

SECONDARY outcome

Timeframe: At delivery, up to 37 weeks of gestation

Population: Participants who received at least one injection of study product

Delivery prior to 37 weeks of gestation that was initiated spontaneously, without provider intervention

Outcome measures

Measure	250 mg 17P n=399 Participants The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. 17P: Synthetic progestin	Placebo n=401 Participants The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. Placebo: Non-active placebo comparator
Number of Participants Experiencing Spontaneous Delivery <37 Weeks	25 Participants	26 Participants

SECONDARY outcome

Timeframe: At delivery, up to 34 weeks of gestation

Population: Participants who received at least one injection of study product

Delivery prior to 34 weeks of gestation that was initiated spontaneously, without provider intervention

Outcome measures

Measure	250 mg 17P n=399 Participants The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. 17P: Synthetic progestin	Placebo n=401 Participants The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. Placebo: Non-active placebo comparator
Number of Participants Experiencing Spontaneous Delivery <34 Weeks	10 Participants	11 Participants

SECONDARY outcome

Timeframe: At delivery, up to 28 weeks of gestation

Population: Participants who received at least one injection of study product

Delivery prior to 28 weeks of gestation that was initiated spontaneously, without provider intervention

Outcome measures

Measure	250 mg 17P n=399 Participants The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. 17P: Synthetic progestin	Placebo n=401 Participants The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. Placebo: Non-active placebo comparator
Number of Participants Experiencing Spontaneous Delivery <28 Weeks	3 Participants	4 Participants

SECONDARY outcome

Timeframe: Birth

Population: Liveborn or stillborn infants weighed at birth

Infant born with a weight below the 10th percentile for gestational age

Outcome measures

Measure	250 mg 17P n=392 Participants The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. 17P: Synthetic progestin	Placebo n=394 Participants The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. Placebo: Non-active placebo comparator
Number of Infants With Birth Weight <10th Percentile for Gestational Age	95 Participants	93 Participants

SECONDARY outcome

Timeframe: Birth

Population: Live born or stillborn infants weighed at birth

Infant born with a weight below the 3rd percentile for gestational age

Outcome measures

Measure	250 mg 17P n=392 Participants The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. 17P: Synthetic progestin	Placebo n=394 Participants The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. Placebo: Non-active placebo comparator
Number of Infants With Birth Weight <3rd Percentile for Gestational Age	28 Participants	47 Participants

SECONDARY outcome

Timeframe: At 6 weeks of life

Population: Infants receiving a test for early infant diagnosis at approximately 6 weeks postpartum

Confirmed HIV infection in an infant

Outcome measures

Measure	250 mg 17P n=374 Participants The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. 17P: Synthetic progestin	Placebo n=379 Participants The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. Placebo: Non-active placebo comparator
Number of Infants Who Experienced Maternal-to-Child HIV Transmission	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Birth through 28 days postpartum

Population: Live born infants for whom follow-up information is available

Death of an infant following live birth

Outcome measures

Measure	250 mg 17P n=388 Participants The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. 17P: Synthetic progestin	Placebo n=386 Participants The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. Placebo: Non-active placebo comparator
Number of Neonatal Deaths	14 Participants	7 Participants

SECONDARY outcome

Timeframe: 1 minute of life

Population: Live born infants for whom an Apgar score was measured at 1 minute of life

Apgar score of less than 7 at 1 minute of life. Apgar stands for "Appearance, Pulse, Grimace, Activity, and Respiration" and is a quick test rated on a scale of 1-10 performed on a baby at one minute of life to determine how well the baby tolerated the birth process. Scores 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.

Outcome measures

Measure	250 mg 17P n=336 Participants The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. 17P: Synthetic progestin	Placebo n=338 Participants The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. Placebo: Non-active placebo comparator
Number of Infants With 1-minute Apgar Score <7	12 Participants	9 Participants

SECONDARY outcome

Timeframe: 5 minutes of life

Population: Live born infants for whom an Apgar score was measured at 5 minutes of life

Apgar score of less than 7 at 5 minutes of life. Apgar stands for "Appearance, Pulse, Grimace, Activity, and Respiration" and is a quick test rated on a scale of 1-10 performed on a baby at five minutes of life to assess how well the baby is doing following delivery. Scores 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.

Outcome measures

Measure	250 mg 17P n=136 Participants The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. 17P: Synthetic progestin	Placebo n=144 Participants The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. Placebo: Non-active placebo comparator
Number of Infants With 5-minute Apgar Score <7	7 Participants	2 Participants

Adverse Events

Mothers: 250 mg 17P

Serious events: 56 serious events

Other events: 43 other events

Deaths: 0 deaths

Mothers: Placebo

Serious events: 55 serious events

Other events: 27 other events

Deaths: 1 deaths

Infants Born to Mothers Receiving 250 mg 17P

Serious events: 33 serious events

Other events: 0 other events

Deaths: 14 deaths

Infants Born to Mothers Receiving Placebo

Serious events: 22 serious events

Other events: 0 other events

Deaths: 7 deaths

Serious adverse events

Measure	Mothers: 250 mg 17P n=399 participants at risk Mothers started study intervention between 16-24 weeks gestation and were administered weekly injections thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner. Participants followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. 17P: Synthetic progestin	Mothers: Placebo n=401 participants at risk Mothers started study intervention between 16-24 weeks gestation and were administered weekly injections thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner. Participants followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. Placebo: Non-active placebo comparator	Infants Born to Mothers Receiving 250 mg 17P n=399 participants at risk Infants born to mothers who started study intervention between 16-24 weeks gestation and were administered weekly injections thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner. Participants followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. 17P: Synthetic progestin	Infants Born to Mothers Receiving Placebo n=401 participants at risk Infants born to mothers who started study intervention between 16-24 weeks gestation and were administered weekly injections thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner. Participants followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. Placebo: Non-active placebo comparator
General disorders Abdominal Pain	1.5% 6/399 • Number of events 7 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	1.7% 7/401 • Number of events 7 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
Blood and lymphatic system disorders Anemia	0.50% 2/399 • Number of events 2 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.75% 3/401 • Number of events 3 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.25% 1/399 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.25% 1/401 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
Metabolism and nutrition disorders Diabetes	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.50% 2/401 • Number of events 2 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
Pregnancy, puerperium and perinatal conditions Eclampsia	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.25% 1/401 • Number of events 2 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
Blood and lymphatic system disorders Edema	0.25% 1/399 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
General disorders Fever	0.25% 1/399 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.25% 1/399 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
Pregnancy, puerperium and perinatal conditions Hemorrhage	1.3% 5/399 • Number of events 5 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	1.00% 4/401 • Number of events 4 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
Pregnancy, puerperium and perinatal conditions Hypertension	0.50% 2/399 • Number of events 2 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.50% 2/401 • Number of events 2 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
General disorders Neonatal Hypothermia	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.25% 1/399 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.25% 1/401 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
Gastrointestinal disorders Neonatal Intestinal Obstruction	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.25% 1/401 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
Hepatobiliary disorders Neonatal Jaundice	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.25% 1/399 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
Infections and infestations Malaria	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.25% 1/401 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
General disorders Neonatal Death of Unknown Cause	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.25% 1/399 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.25% 1/401 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
Infections and infestations Presumed Neonatal Sepsis	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	1.5% 6/399 • Number of events 7 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.50% 2/401 • Number of events 3 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
General disorders Nose Bleed / Laceration	0.25% 1/399 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.25% 1/401 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.25% 1/401 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.50% 2/399 • Number of events 2 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
Pregnancy, puerperium and perinatal conditions Premature Rupture of Membranes	0.50% 2/399 • Number of events 2 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.50% 2/401 • Number of events 2 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
Pregnancy, puerperium and perinatal conditions Preeclampsia	1.3% 5/399 • Number of events 6 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	1.00% 4/401 • Number of events 5 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
Nervous system disorders Neonatal Encephelopathy	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	1.5% 6/399 • Number of events 6 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.50% 2/401 • Number of events 3 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
Psychiatric disorders Presumed Psychosis	0.25% 1/399 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
Pregnancy, puerperium and perinatal conditions Preterm labor	0.25% 1/399 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.25% 1/401 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
Pregnancy, puerperium and perinatal conditions Puerperal Sepsis	0.25% 1/399 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
Respiratory, thoracic and mediastinal disorders Neonatal Respiratory Distress Syndrome	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	3.5% 14/399 • Number of events 14 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	2.5% 10/401 • Number of events 10 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
Pregnancy, puerperium and perinatal conditions Stillbirth	2.5% 10/399 • Number of events 10 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	2.2% 9/401 • Number of events 9 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
General disorders Syncope	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.25% 1/401 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
Respiratory, thoracic and mediastinal disorders Respiratory Tract Infection	0.25% 1/399 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.25% 1/401 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.25% 1/401 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
Renal and urinary disorders Urinary Tract Infection	2.0% 8/399 • Number of events 9 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	2.7% 11/401 • Number of events 11 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
Gastrointestinal disorders Bowel Perforation	0.25% 1/399 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
General disorders Left Side Pain	0.25% 1/399 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
Pregnancy, puerperium and perinatal conditions Cesarean Scar Tenderness	0.25% 1/399 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
General disorders Abdominal Trauma	0.25% 1/399 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
Gastrointestinal disorders Gastroenteritis	0.25% 1/399 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.25% 1/401 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
Metabolism and nutrition disorders Neonatal Hypoglecemia	0.25% 1/399 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
General disorders General Malaise	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.25% 1/401 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
General disorders Neonatal Dehydration	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.25% 1/401 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
Pregnancy, puerperium and perinatal conditions Placental Abruption	0.25% 1/399 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
Infections and infestations Pulmonary Tuberculosis	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.25% 1/401 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
Pregnancy, puerperium and perinatal conditions Prematurity	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.50% 2/401 • Number of events 2 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
Renal and urinary disorders Kidney Infection	0.50% 2/399 • Number of events 2 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
Renal and urinary disorders Bladder Injury	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.25% 1/401 • Number of events 1 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks

Other adverse events

Measure	Mothers: 250 mg 17P n=399 participants at risk Mothers started study intervention between 16-24 weeks gestation and were administered weekly injections thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner. Participants followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. 17P: Synthetic progestin	Mothers: Placebo n=401 participants at risk Mothers started study intervention between 16-24 weeks gestation and were administered weekly injections thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner. Participants followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. Placebo: Non-active placebo comparator	Infants Born to Mothers Receiving 250 mg 17P n=399 participants at risk Infants born to mothers who started study intervention between 16-24 weeks gestation and were administered weekly injections thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner. Participants followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. 17P: Synthetic progestin	Infants Born to Mothers Receiving Placebo n=401 participants at risk Infants born to mothers who started study intervention between 16-24 weeks gestation and were administered weekly injections thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner. Participants followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. Placebo: Non-active placebo comparator
Product Issues Headache	6.3% 25/399 • Number of events 26 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	4.2% 17/401 • Number of events 17 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
Product Issues Diarrhea	4.5% 18/399 • Number of events 19 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	2.5% 10/401 • Number of events 10 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/399 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks	0.00% 0/401 • From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks

Additional Information

Joan Price, MD, MPH

University of North Carolina at Chapel Hill

Phone: 919-962-4717

Email: joan_price@med.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place