Trial Outcomes & Findings for Pravastatin to Prevent Preeclampsia (NCT NCT03944512)

Results Overview

Proportion of participants demonstrating a composite of preeclampsia, fetal loss, or maternal death. 1. Baseline Normotensive: a) Severe hypertension (HTN) or b) Mild HTN w/ any of the following: i.) New-onset proteinuria or doubling in protein w/ baseline proteinuria ii.) Thrombocytopenia iii.) Progressive renal insufficiency iv). Impaired liver function v.) Pulmonary edema vi.) New-onset \& persistent cerebral or visual symptoms 2. Baseline chronic HTN: any of the following a)Severe HTN b) New onset proteinuria or doubling in protein from baseline proteinuria c)Thrombocytopenia d) Progressive renal insufficiency e) Impaired liver function f) Pulmonary edema g) New-onset \& persistent cerebral or visual symptoms. 3. HELLP a) Hemolysis AND b)Thrombocytopenia AND c) AST/ALT ≥ 70 IU/L 4. Atypical HELLP an occurrence of 2 of the 3: a) Hemolysis, b)Thrombocytopenia, OR c) AST/ALT ≥ 70 IU/L 5. Eclampsia 6. Competing outcomes: maternal death before delivery or fetal loss \< 20wks, 0 days

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

102 participants

Primary outcome timeframe

48 hours postpartum

Results posted on

2025-12-23

Participant Flow

This trial began under an FDA clinical hold that limited recruitment to 50 participants of the planned 1,550. The hold was not lifted and the trial was terminated after enrollment of the first 50 participants. We conducted the trial at 13 hospitals. Mothers were enrolled in pregnancy and their offspring followed for 2 years. Recruitment period was Jul 2019 to Dec 2020. Infants were enrolled but were not consented. Two mothers delivered twins resulting in 52 fetus/neonates (26 in each arm).

Participant milestones

Participant milestones
Measure	Pravastatin 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo Identical appearing daily placebo Placebo: Identical appearing placebo pill	Pravastatin - Fetus/ Neonates /Infants Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group	Placebo - Fetus/ Neonates /Infants Fetus/Neonates /Infants of participants in the placebo group
Overall Study STARTED	25	25	26	26
Overall Study COMPLETED	25	25	19	18
Overall Study NOT COMPLETED	0	0	7	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Pravastatin - Fetus/ Neonates /Infants Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group	Placebo - Fetus/ Neonates /Infants Fetus/Neonates /Infants of participants in the placebo group
Overall Study Death	1	2
Overall Study Lost to Follow-up	4	4
Overall Study refused follow-up	2	2

Baseline Characteristics

Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pravastatin n=25 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=25 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill	Pravastatin - Fetus/ Neonates /Infants Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group	Placebo - Fetus/ Neonates /Infants Fetus/Neonates /Infants of participants in the placebo group	Total n=50 Participants Total of all reporting groups
Age, Continuous	31.6 years STANDARD_DEVIATION 4.7 • n=68 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.	31.6 years STANDARD_DEVIATION 6.8 • n=4 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.	—	—	31.6 years STANDARD_DEVIATION 5.8 • n=880 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.
Sex: Female, Male Female	25 Participants n=68 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.	25 Participants n=4 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.	—	—	50 Participants n=880 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.
Sex: Female, Male Male	0 Participants n=68 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.	0 Participants n=4 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.	—	—	0 Participants n=880 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.
Race/Ethnicity, Customized American Indian/Alaskan Native	1 Participants n=68 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.	0 Participants n=4 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.	—	—	1 Participants n=880 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.
Race/Ethnicity, Customized Asian	0 Participants n=68 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.	2 Participants n=4 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.	—	—	2 Participants n=880 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.
Race/Ethnicity, Customized Hispanic	9 Participants n=68 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.	8 Participants n=4 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.	—	—	17 Participants n=880 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.
Race/Ethnicity, Customized Native Hawaiian / Pacific Islander	0 Participants n=68 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.	0 Participants n=4 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.	—	—	0 Participants n=880 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.
Race/Ethnicity, Customized Non-Hispanic Black	4 Participants n=68 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.	6 Participants n=4 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.	—	—	10 Participants n=880 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.
Race/Ethnicity, Customized Non-Hispanic White	11 Participants n=68 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.	9 Participants n=4 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.	—	—	20 Participants n=880 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.
Race/Ethnicity, Customized More than 1 self-reported race	0 Participants n=68 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.	0 Participants n=4 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.	—	—	0 Participants n=880 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.
Chronic Hypertension	13 Participants n=68 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.	10 Participants n=4 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.	—	—	23 Participants n=880 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.
Twin pregnancy	1 Participants n=68 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.	1 Participants n=4 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.	—	—	2 Participants n=880 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.
Gestational age at randomization	14.1 weeks n=68 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.	15.4 weeks n=4 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.	—	—	14.9 weeks n=880 Participants • Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.

PRIMARY outcome

Timeframe: 48 hours postpartum

Proportion of participants demonstrating a composite of preeclampsia, fetal loss, or maternal death. 1. Baseline Normotensive: a) Severe hypertension (HTN) or b) Mild HTN w/ any of the following: i.) New-onset proteinuria or doubling in protein w/ baseline proteinuria ii.) Thrombocytopenia iii.) Progressive renal insufficiency iv). Impaired liver function v.) Pulmonary edema vi.) New-onset \& persistent cerebral or visual symptoms 2. Baseline chronic HTN: any of the following a)Severe HTN b) New onset proteinuria or doubling in protein from baseline proteinuria c)Thrombocytopenia d) Progressive renal insufficiency e) Impaired liver function f) Pulmonary edema g) New-onset \& persistent cerebral or visual symptoms. 3. HELLP a) Hemolysis AND b)Thrombocytopenia AND c) AST/ALT ≥ 70 IU/L 4. Atypical HELLP an occurrence of 2 of the 3: a) Hemolysis, b)Thrombocytopenia, OR c) AST/ALT ≥ 70 IU/L 5. Eclampsia 6. Competing outcomes: maternal death before delivery or fetal loss \< 20wks, 0 days

Outcome measures

Outcome measures
Measure	Pravastatin n=25 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=25 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Proportion of Participants With Composite of Preeclampsia, Fetal Loss and Maternal Death	10 Participants	15 Participants

SECONDARY outcome

Timeframe: 48 hours postpartum

Preeclampsia with severe features as defined by the American College of Obstetricians and Gynecologists (ACOG) diagnostic criteria (i.e., severe hypertension, thrombocytopenia, impaired liver function, progressive renal insufficiency, pulmonary edema, new-onset and persistent cerebral or visual symptoms)

Outcome measures

Outcome measures
Measure	Pravastatin n=25 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=25 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Proportion of Participants With Preeclampsia With Severe Features	2 Participants	4 Participants

SECONDARY outcome

Timeframe: 48 hours postpartum

Defined as new onset hypertension in the absence of accompanying proteinuria or other features of preeclampsia

Outcome measures

Outcome measures
Measure	Pravastatin n=25 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=25 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Proportion of Participants With Gestational Hypertension	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 48 hours postpartum

Defined as gestational hypertension or preeclampsia

Outcome measures

Outcome measures
Measure	Pravastatin n=25 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=25 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Proportion of Participants With Pregnancy Associated Hypertension	5 Participants	9 Participants

SECONDARY outcome

Timeframe: 48 hours postpartum through 6 weeks post partum

Preeclampsia that occurs more than 48 hours after birth

Outcome measures

Outcome measures
Measure	Pravastatin n=25 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=23 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Proportion of Participants With Postpartum Preeclampsia	1 Participants	0 Participants

SECONDARY outcome

Timeframe: At any time during pregnancy through delivery (up to approximately 30 weeks)

Gestational diabetes mellitus

Outcome measures

Outcome measures
Measure	Pravastatin n=25 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=25 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Proportion of Participants With Gestational Diabetes	7 Participants	4 Participants

SECONDARY outcome

Timeframe: Randomization to delivery (up to approximately 30 weeks)

Adherence to the medication regimen for the study (daily pill) defined as the time from randomization to delivery. The earliest gestational age at randomization is 12 weeks and most women deliver by 42 weeks gestation which is why the time frame is up to a maximum of approximately 30 weeks. Given the earlier gestational age of delivery in this cohort, the time period is shorter than 30 weeks.

Outcome measures

Outcome measures
Measure	Pravastatin n=25 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=25 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Rate of Adherence to Study Medication	88.8 percentage of compliance Interval 0.0 to 100.0	90.3 percentage of compliance Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: Randomization through 6 weeks postpartum

A composite of severe maternal morbidity of either maternal death, eclampsia, HELLP syndrome, cerebral vascular accident, heart failure, myocardial infarction, acute respiratory distress syndrome requiring mechanical ventilation, disseminated intravascular coagulopathy, pulmonary edema, renal failure, liver rupture, or placental abruption

Outcome measures

Outcome measures
Measure	Pravastatin n=25 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=25 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Proportion of Participants With Severe Maternal Morbidity Composite	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Delivery admission through discharge from the hospital (a median of 3 days)

Length of maternal hospital stay for the delivery admission (admission to discharge)

Outcome measures

Outcome measures
Measure	Pravastatin n=25 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=25 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Length of Maternal Hospital Stay	3 days Interval 1.0 to 10.0	3 days Interval 1.0 to 44.0

SECONDARY outcome

Timeframe: Randomization through 48 hours postpartum

Adverse events of Special Interest (AESI) including myalgia and muscle weakness, and serious AESI include maternal myositis, myopathy, rhabdomyolysis, or serious liver injury

Outcome measures

Outcome measures
Measure	Pravastatin n=25 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=25 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Rate of Adverse Events of Special Interest (AESI) or Serious AESI	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Delivery

Population: For twin gestation, the worst outcome for the twin pair is analyzed/reported.

Gestational age at the time of delivery

Outcome measures

Outcome measures
Measure	Pravastatin n=25 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=25 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Gestational Age at Delivery	36.7 weeks Interval 29.0 to 39.9	37.0 weeks Interval 16.3 to 39.4

SECONDARY outcome

Timeframe: Delivery before 37 weeks

Population: For twin gestation, the worst outcome for the twin pair is analyzed/reported.

Preterm birth before 37 weeks gestation

Outcome measures

Outcome measures
Measure	Pravastatin n=25 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=25 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Proportion of Participants With Preterm Birth < 37 Weeks	14 Participants	11 Participants

SECONDARY outcome

Timeframe: Delivery before 37 weeks

Population: For twin gestation, the worst outcome for the twin pair is analyzed/reported.

Indicated preterm birth less than 37 weeks

Outcome measures

Outcome measures
Measure	Pravastatin n=25 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=25 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Proportion of Participants With Indicated Preterm Birth < 37 Weeks	9 Participants	7 Participants

SECONDARY outcome

Timeframe: Delivery before 34 weeks

Population: For twin gestation, the worst outcome for the twin pair is analyzed/reported.

Preterm birth before 34 weeks gestation

Outcome measures

Outcome measures
Measure	Pravastatin n=25 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=25 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Proportion of Participants With Preterm Birth < 34 Weeks	4 Participants	7 Participants

SECONDARY outcome

Timeframe: randomization (mother) through 28 days of life (neonate)

Population: For twin gestation, the worst outcome for the twin pair is analyzed/reported.

Death of the fetus or neonate

Outcome measures

Outcome measures
Measure	Pravastatin n=25 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=25 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Proportion of Fetal or Neonatal Deaths	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Birth

Population: Liveborn neonates only. For twin gestation, the worst outcome for the twin pair is analyzed/reported.

Birth weight

Outcome measures

Outcome measures
Measure	Pravastatin n=25 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=23 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Birth Weight	2626 grams Standard Deviation 668	2543 grams Standard Deviation 884

SECONDARY outcome

Timeframe: Birth

Population: Liveborn neonates only. For twin gestation, the worst outcome for the twin pair is analyzed/reported.

Birthweight \< 5th percentile

Outcome measures

Outcome measures
Measure	Pravastatin n=25 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=23 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Proportion of Small for Gestational Age < 5th Percentile	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Birth

Population: Liveborn neonates only. For twin gestation, the worst outcome for the twin pair is analyzed/reported.

Birthweight \< 10th percentile

Outcome measures

Outcome measures
Measure	Pravastatin n=25 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=23 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Proportion of Small for Gestational Age < 10th Percentile	7 Participants	6 Participants

SECONDARY outcome

Timeframe: Birth through hospital discharge (an average of 4 days)

Population: Liveborn neonates only. For twin gestation, the worst outcome for the twin pair is analyzed/reported. Data missing for 1 pravastatin and 1 placebo participant.

Admission to the neonatal intensive care unit (NICU) or intermediate nursery

Outcome measures

Outcome measures
Measure	Pravastatin n=24 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=22 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Proportion of NICU/Intermediate Nursery Admission	11 Participants	9 Participants

SECONDARY outcome

Timeframe: Birth through hospital discharge (an average of 4 days)

Population: Neonates admitted to the NICU. For twin gestation, the worst outcome for the twin pair is analyzed/reported.

Length of stay in the neonatal intensive care unit (NICU) and/or intermediate nursery.

Outcome measures

Outcome measures
Measure	Pravastatin n=11 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=9 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
NICU/Intermediate Nursery Length of Stay	13 days Interval 2.0 to 83.0	42 days Interval 3.0 to 220.0

SECONDARY outcome

Timeframe: Birth through hospital discharge (an average of 4 days)

Population: Liveborn neonates only. For twin gestation, the worst outcome for the twin pair is analyzed/reported. Data missing for 1 pravastatin and 2 placebo participants.

Mechanical ventilation or CPAP support

Outcome measures

Outcome measures
Measure	Pravastatin n=24 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=21 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Proportion of Neonates Needing Mechanical Ventilation or Continuous Positive Airway Pressure (CPAP)	7 Participants	4 Participants

SECONDARY outcome

Timeframe: Birth through hospital discharge (an average of 4 days)

Population: Liveborn neonates only. For twin gestation, the worst outcome for the twin pair is analyzed/reported. Data missing for 1 pravastatin and 2 placebo participants.

Provision of oxygen support for the neonate

Outcome measures

Outcome measures
Measure	Pravastatin n=24 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=21 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Proportion of Neonates Needing Oxygen Support	6 Participants	4 Participants

SECONDARY outcome

Timeframe: Birth through hospital discharge (an average of 4 days)

Population: Liveborn neonates only. For twin gestation, the worst outcome for the twin pair is analyzed/reported. Data missing for 1 pravastatin and 1 placebo participant.

Respiratory distress syndrome (RDS), defined as the presence of clinical signs of respiratory distress (tachypnea, retractions, flaring, grunting, or cyanosis), with an oxygen requirement and confirmed by a chest x-ray

Outcome measures

Outcome measures
Measure	Pravastatin n=24 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=22 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Proportion of Neonates With Respiratory Distress Syndrome	3 Participants	4 Participants

SECONDARY outcome

Timeframe: 28 days of life and 36 weeks corrected gestational age

Population: Liveborn neonates only. For twin gestation, the worst outcome for the twin pair is analyzed/reported. Data missing for 1 pravastatin and 1 placebo participant.

Bronchopulmonary dysplasia (BPD), defined as oxygen requirement at 28 days of life and at 36 weeks corrected gestational age

Outcome measures

Outcome measures
Measure	Pravastatin n=24 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=22 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Proportion of Neonates With Bronchopulmonary Dysplasia	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Birth through hospital discharge (an average of 4 days)

Population: Liveborn neonates only. For twin gestation, the worst outcome for the twin pair is analyzed/reported. Data missing for 1 pravastatin and 1 placebo participant.

Necrotizing enterocolitis (NEC), defined as modified Bell Stage 2 (clinical signs and symptoms with pneumatosis intestinalis on radiographs) or Stage 3 (advanced clinical signs and symptoms, pneumatosis, impending or proven intestinal perforation)

Outcome measures

Outcome measures
Measure	Pravastatin n=24 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=22 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Proportion of Neonates With Necrotizing Enterocolitis	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Birth through hospital discharge (an average of 4 days)

Population: Liveborn neonates only. For twin gestation, the worst outcome for the twin pair is analyzed/reported. Data missing for 1 pravastatin and 1 placebo participant.

Intraventricular hemorrhage (IVH) grade III-IV

Outcome measures

Outcome measures
Measure	Pravastatin n=24 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=22 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Proportion of Neonates With Intraventricular Hemorrhage	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Birth through hospital discharge (an average of 4 days)

Population: Liveborn neonates only. For twin gestation, the worst outcome for the twin pair is analyzed/reported. Data missing for 1 pravastatin and 1 placebo participant.

Periventricular leukomalacia (PVL), diagnosed by neuroimaging

Outcome measures

Outcome measures
Measure	Pravastatin n=24 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=22 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Proportion of Neonates With Periventricular Leukomalacia (PVL)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Birth to 72 hours from birth

Population: Liveborn neonates only. For twin gestation, the worst outcome for the twin pair is analyzed/reported. Data missing for 1 pravastatin and 1 placebo participant.

Neonatal sepsis (within first 72 hours after birth). The diagnosis of sepsis will require the presence of a clinically ill infant in whom systemic infection is suspected with a positive blood, cerebral spinal fluid (CSF), or catheterized/suprapubic urine culture; or, in the absence of positive cultures, clinical evidence of cardiovascular collapse or an unequivocal radiograph confirming infection.

Outcome measures

Outcome measures
Measure	Pravastatin n=24 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=22 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Proportion of Neonates Experiencing Early Onset Sepsis	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Birth through hospital discharge (an average of 4 days)

Population: Liveborn neonates only. For twin gestation, the worst outcome for the twin pair is analyzed/reported. Data missing for 1 pravastatin and 1 placebo participant.

Neonatal sepsis (\>72 hours after birth). The diagnosis of sepsis will require the presence of a clinically ill infant in whom systemic infection is suspected with a positive blood, cerebral spinal fluid (CSF), or catheterized/suprapubic urine culture; or, in the absence of positive cultures, clinical evidence of cardiovascular collapse or an unequivocal radiograph confirming infection.

Outcome measures

Outcome measures
Measure	Pravastatin n=24 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=22 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Proportion of Neonates Experiencing Late Onset Sepsis	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Birth through hospital discharge (an average of 4 days)

Population: Liveborn neonates only. For twin gestation, the worst outcome for the twin pair is analyzed/reported. Data missing for 1 pravastatin and 1 placebo participant.

Retinopathy of prematurity (ROP) stage III or higher

Outcome measures

Outcome measures
Measure	Pravastatin n=24 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=22 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Proportion of Neonates With Retinopathy of Prematurity	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Birth through hospital discharge (an average of 4 days)

Population: For twin gestation, the worst outcome for the twin pair is analyzed/reported. Data missing for 1 placebo participant.

Fetal or neonatal death, RDS, Grade III-IV IVH, PVL, Stage 2 or 3 NEC, BPD, Stage III or higher ROP, or early onset sepsis

Outcome measures

Outcome measures
Measure	Pravastatin n=25 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=24 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Proportion of Neonates With Composite Neonatal Outcome	4 Participants	6 Participants

SECONDARY outcome

Timeframe: Birth through hospital discharge (an average of 4 days)

Population: Liveborn neonates only. For twin gestation, the worst outcome for the twin pair is analyzed/reported. Data missing for 1 pravastatin and 1 placebo participant.

Neonatal seizure activity

Outcome measures

Outcome measures
Measure	Pravastatin n=24 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=22 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Proportion of Neonates Experiencing Seizures	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Randomization through delivery (up to approximately 30 weeks)

Population: For twin gestation, the worst outcome for the twin pair is analyzed/reported. Data missing for 1 placebo participant.

Congenital anomaly or birth defect excluding any conditions that must have been present before randomization

Outcome measures

Outcome measures
Measure	Pravastatin n=25 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=24 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Proportion of Neonates With a Congenital Anomaly / Birth Defect	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Birth through hospital discharge (an average of 4 days)

Population: Liveborn neonates only. For twin gestation, the worst outcome for the twin pair is analyzed/reported. Data missing for 1 pravastatin and 1 placebo participant.

Neonatal auditory brain stem response (ABR)/Otoacoustic Emissions (OAE) test results of fail/refer.

Outcome measures

Outcome measures
Measure	Pravastatin n=24 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=22 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Neonatal Auditory Brain Stem Response (ABR)/Otoacoustic Emissions (OAE)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 months of age

Body mass index for age percentile at 24 corrected months using Centers for Disease Control (CDC) pediatric growth charts

Outcome measures

Outcome measures
Measure	Pravastatin n=16 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=15 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
BMI for Age at 24 Corrected Months	83.8 percentile Interval 0.3 to 98.7	50.6 percentile Interval 0.3 to 96.8

SECONDARY outcome

Timeframe: 24 months of age

Bayley Certified Scales of Infant Development III Edition standard score for cognitive abilities at 24 months of age. Composite standard scores are derived for cognitive, language, and motor development and scaled to a metric, with a mean of 100, standard deviation of 15, and range of 40 to 160. Higher scores mean better outcome.

Outcome measures

Outcome measures
Measure	Pravastatin n=16 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=14 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Cognitive Standard Score From the Bayley Certified Scales of Infant Development III Edition at 24 Months of Age	93.8 score on a scale Standard Deviation 10.2	87.9 score on a scale Standard Deviation 14.6

SECONDARY outcome

Timeframe: 24 months of age

Bayley Certified Scales of Infant Development III Edition standard score for motor abilities at 24 months of age. Composite standard scores are derived for cognitive, language, and motor development and scaled to a metric, with a mean of 100, standard deviation of 15, and range of 40 to 160. Higher scores mean better outcome.

Outcome measures

Outcome measures
Measure	Pravastatin n=15 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=13 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Motor Standard Score From the Bayley Certified Scales of Infant Development III Edition at 24 Months of Age	90.5 score on a scale Standard Deviation 9.2	88.2 score on a scale Standard Deviation 11.9

SECONDARY outcome

Timeframe: 24 months of age

Bayley Certified Scales of Infant Development III Edition standard score for language abilities at 24 months of age. Composite standard scores are derived for cognitive, language, and motor development and scaled to a metric, with a mean of 100, standard deviation of 15, and range of 40 to 160. Higher scores mean better outcome.

Outcome measures

Outcome measures
Measure	Pravastatin n=15 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=13 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Language Standard Score From the Bayley Certified Scales of Infant Development III Edition at 24 Months of Age	88.9 score on a scale Standard Deviation 16.7	87.8 score on a scale Standard Deviation 20.1

SECONDARY outcome

Timeframe: 24 months of age

Level from the Gross Motor Function Classification System at 24 months of age Level I (Handles objects easily and successfully) Level II (Handles most objects, but with somewhat reduced quality and/or speed of achievement) Level III (Handles objects with difficulty) Level IV (Handles a limited selection of easily managed objects in simple actions) Level V (Does not handle objects and has severely limited ability to perform even simple actions)

Outcome measures

Outcome measures
Measure	Pravastatin n=19 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=17 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Gross Motor Function Classification System at 24 Months of Age Level I	18 Participants	16 Participants
Gross Motor Function Classification System at 24 Months of Age Level II	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 24 months of age

Hearing loss at 24 months of age

Outcome measures

Outcome measures
Measure	Pravastatin n=19 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=17 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Proportion of Children With Hearing Loss at 24 Months of Age	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 24 months of age

Total problems T score from the Child Behavior Checklist (CBCL) at 24 months. The Child Behavior Checklist (CBCL) is a survey used to detect behavioral and emotional problems in children. The CBCL is filled out by the caregiver. Each of the 100 questions indicates a behavior for which the caregiver scores as Not True (0), Sometimes True (1), or Often True (2). The scores for all the questions are then summed and evaluated against the normative data/T-scores. The raw total scores are converted to norm-referenced T-scores (mean 50, standard deviation of 10). Lower scores represent better outcomes. A T-score of 64 or higher indicates a clinically significant elevation. Lower scores represent better outcomes.

Outcome measures

Outcome measures
Measure	Pravastatin n=19 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=16 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Child Behavior Checklist Total Problems T-Score at 24 Months	45 T-score Interval 28.0 to 53.0	44.5 T-score Interval 30.0 to 84.0

SECONDARY outcome

Timeframe: 24 months of age

Vision problems (severe nearsightedness or farsightedness, and eye movement problems) at 24 months of age

Outcome measures

Outcome measures
Measure	Pravastatin n=19 Participants 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo n=17 Participants Identical appearing daily placebo Placebo: Identical appearing placebo pill
Proportion of Children With Vision Problems at 24 Months of Age	0 Participants	1 Participants

Adverse Events

20mg Pravastatin - Mother

Serious events: 4 serious events

Other events: 12 other events

Deaths: 1 deaths

Placebo - Mother

Serious events: 5 serious events

Other events: 11 other events

Deaths: 0 deaths

20mg Pravastatin - Fetus/ Neonates /Infants

Serious events: 5 serious events

Other events: 0 other events

Deaths: 1 deaths

Placebo - Fetus/ Neonates /Infants

Serious events: 5 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	20mg Pravastatin - Mother n=25 participants at risk 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily	Placebo - Mother n=24 participants at risk；n=25 participants at risk Identical appearing daily placebo Placebo: Identical appearing placebo pill	20mg Pravastatin - Fetus/ Neonates /Infants n=26 participants at risk Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group	Placebo - Fetus/ Neonates /Infants n=26 participants at risk Fetus/Neonates /Infants of participants in the placebo group
General disorders Headache	28.0% 7/25 • Number of events 7 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.	20.8% 5/24 • Number of events 5 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.	— 0/0 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.	— 0/0 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.
General disorders Fatigue	16.0% 4/25 • Number of events 4 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.	12.5% 3/24 • Number of events 3 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.	— 0/0 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.	— 0/0 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.
General disorders Dizziness	8.0% 2/25 • Number of events 2 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.	8.3% 2/24 • Number of events 2 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.	— 0/0 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.	— 0/0 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.
Gastrointestinal disorders Nausea	8.0% 2/25 • Number of events 2 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.	16.7% 4/24 • Number of events 4 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.	— 0/0 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.	— 0/0 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.
Gastrointestinal disorders Vomiting	4.0% 1/25 • Number of events 1 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.	12.5% 3/24 • Number of events 3 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.	— 0/0 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.	— 0/0 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.
Musculoskeletal and connective tissue disorders Muscle Weakness	8.0% 2/25 • Number of events 2 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.	8.3% 2/24 • Number of events 2 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.	— 0/0 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.	— 0/0 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.
Musculoskeletal and connective tissue disorders Muscle Pain	8.0% 2/25 • Number of events 2 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.	0.00% 0/24 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.	— 0/0 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.	— 0/0 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.
Psychiatric disorders Anxiety/nervousness	8.0% 2/25 • Number of events 2 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.	8.3% 2/24 • Number of events 2 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.	— 0/0 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.	— 0/0 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.
Respiratory, thoracic and mediastinal disorders Influenza-like Symptoms	8.0% 2/25 • Number of events 2 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.	8.3% 2/24 • Number of events 2 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.	— 0/0 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.	— 0/0 • Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates. Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.

Additional Information

Maged M. Costantine, MD

The Ohio State University

Phone: 614-293-9036

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place