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

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)

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

Defined as gestational hypertension or preeclampsia

Preeclampsia that occurs more than 48 hours after birth

Gestational diabetes mellitus

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.

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

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

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

Gestational age at the time of delivery

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

Preterm birth before 37 weeks gestation

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

Indicated preterm birth less than 37 weeks

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

Preterm birth before 34 weeks gestation

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

Death of the fetus or neonate

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

Birth weight

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

Birthweight < 5th percentile

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

Birthweight < 10th percentile

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

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

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.

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

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

Mechanical ventilation or CPAP support

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

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.

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

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

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)

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

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

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.

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.

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

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.

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

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

Neonatal seizure activity

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.

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

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

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

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.

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

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.

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.

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.

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)

Hearing loss at 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.

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