PreeclampsiaPhase 3PravastatinNCT03944512
Pravastatin to Prevent Preeclampsia
A Phase 3 study testing Pravastatin in people with Preeclampsia and Obstetric Labor Complications, run by The George Washington University Biostatistics Center at 12 sites in United States.
Trial summary
This study is a double-blind randomized placebo-controlled trial of 1,550 high-risk women to assess whether daily treatment with pravastatin administered early in pregnancy reduces the rate of a composite outcome of preeclampsia, fetal loss and maternal death. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Preeclampsia, Obstetric Labor Complications, Hypertension in Pregnancy
- What is being tested?
- Pravastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 12 sitesUnited States
- Study dates
- 17 Jul 2019to 20 Jun 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 16 years or older at time of consent with ability to give informed consent
- Single or twin gestation with cardiac activity in one or both fetuses. Higher order multifetal gestations reduced to twins, either spontaneously or therapeutically, are not eligible unless the reduction occurred by 13 weeks 6 days project gestational age.
- Gestational age at randomization between 12 weeks 0 days and 16 weeks 6 days based on clinical information and evaluation of the earliest ultrasound.
- Documented history (by chart or delivery/operative note review) of prior preeclampsia with delivery less than or equal to 34 weeks 0 days gestation in any previous pregnancy. If in the index pregnancy, the woman was induced by 34 weeks 0 days gestation and delivered within 48 hours in the same hospitalization, that woman would be eligible.
- Normal serum transaminase (AST/ALT) concentrations documented in the last 6 months.
Who cannot join
- Monoamniotic gestation because of the risk of fetal demise
- Known chromosomal, genetic or major malformations
- Fetal demise or planned termination of pregnancy. Selective reduction by 13 weeks 6 days gestation, from triplets to twins or twins to singleton is not an exclusion.
- Contraindications for statin therapy:
- Hypersensitivity to pravastatin or any component of the product
- Active liver disease: acute hepatitis or chronic active hepatitis
Show all 15Show fewer
- Statin use in current pregnancy
- Patients with any of the following medical conditions:
- Uncontrolled hypothyroidism with a TSH level above 10 mIU/L, because of increased risk of myopathy
- HIV positive, because of increased risk of myopathy with use of protease inhibitors
- Chronic renal disease with baseline serum creatinine ≥1.5 mg/dL, because of association with adverse pregnancy outcomes
- Current use of concomitant medication with potential for drug interaction with statins (i.e.,, cyclosporine, fibrates, niacin, erythromycin). Patients will not be excluded if the drug is discontinued (at least one week) prior to randomization.
- Participating in another intervention study that influences the primary outcome in this study
- Plan to deliver in a non-network site
- Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, do not have to be excluded.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of Alabama - Birmingham
Birmingham, Alabama, 35233
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
Northwestern University
Chicago, Illinois, 60611
Case Western Reserve-Metro Health
Cleveland, Ohio, 44109
Ohio State University Hospital
Columbus, Ohio, 43210
University of Texas Medical Branch
Galveston, Texas, 77555
University of Texas - Houston
Houston, Texas, 77030
Columbia University
New York, New York, 10032
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Magee Women's Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
Brown University
Providence, Rhode Island, 02905
University of Utah Medical Center
Salt Lake City, Utah, 84132
About this study
Official title: A Randomized Controlled Trial of Pravastatin to Prevent Preeclampsia in High Risk Women
This study is a double-blind randomized placebo-controlled trial of 1,550 high-risk women to assess whether daily treatment with pravastatin administered early in pregnancy reduces the rate of a composite outcome of preeclampsia, fetal loss and maternal death. Women with a prior history of preeclampsia with preterm delivery less than 34 weeks will be randomized to pravastatin or placebo daily until delivery. Women will have monthly study visits during pregnancy, a follow-up visit at 6 weeks postpartum and children will have follow-up visits at 2 and 5 years of age.
Read the detailed description
Preeclampsia complicates approximately 3% to 5% of pregnancies and remains a major cause of maternal and neonatal morbidities and mortality. Women who experience preeclampsia in one pregnancy are at higher risk of developing preeclampsia in a subsequent pregnancy than those who have never experienced the condition. There is evidence from laboratory studies and clinical trials, as well as biological plausibility, to suggest that statins may prevent the development of preeclampsia by reversing various pathways associated with preeclampsia. Pravastatin has a favorable safety profile and pharmacokinetic properties.
The study is a randomized placebo-controlled multi-center clinical trial of 1,550 women with a prior history of preeclampsia that required delivery at less than 34 weeks, randomized to either 20mg pravastatin or an identical appearing placebo daily until delivery. Women with a singleton or twin gestation will be randomized between 12 weeks 0 days and 16 weeks 6 days will be followed monthly during pregnancy and then at 6 weeks postpartum. Children will have follow-up visits at 2 and 5 years of age to assess growth, cognition, behavior, motor skills, vision and hearing.
- Being tested
- Pravastatin, Placebo
- Keywords
- Pregnancy, Preeclampsia
- Medical subject headings
- Pre-Eclampsia, Obstetric Labor Complications, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PravastatinDrug
20 mg Pravastatin taken daily
PlaceboOther
Identical appearing placebo pill
| Study group | Role | What they receive |
|---|---|---|
| Pravastatin | Experimental | 20 mg pravastatin daily Receives: Drug: Pravastatin |
| Placebo | Placebo comparator | Identical appearing daily placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Composite of Preeclampsia, Fetal Loss and Maternal Death
Proportion of participants demonstrating a composite of preeclampsia, fetal loss, or maternal death.
- 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
- 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.
- HELLP a) Hemolysis AND b)Thrombocytopenia AND c) AST/ALT ≥ 70 IU/L
- Atypical HELLP an occurrence of 2 of the 3: a) Hemolysis, b)Thrombocytopenia, OR c) AST/ALT ≥ 70 IU/L
- Eclampsia
- Competing outcomes: maternal death before delivery or fetal loss < 20wks, 0 days
Measured: 48 hours postpartum
Secondary outcomes (41)
Proportion of Participants With Preeclampsia With Severe Features
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)
Measured: 48 hours postpartum
Proportion of Participants With Gestational Hypertension
Defined as new onset hypertension in the absence of accompanying proteinuria or other features of preeclampsia
Measured: 48 hours postpartum
Proportion of Participants With Pregnancy Associated Hypertension
Defined as gestational hypertension or preeclampsia
Measured: 48 hours postpartum
Proportion of Participants With Postpartum Preeclampsia
Preeclampsia that occurs more than 48 hours after birth
Measured: 48 hours postpartum through 6 weeks post partum
Proportion of Participants With Gestational Diabetes
Gestational diabetes mellitus
Measured: At any time during pregnancy through delivery (up to approximately 30 weeks)
Rate of Adherence to Study Medication
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.
Measured: Randomization to delivery (up to approximately 30 weeks)
Proportion of Participants With Severe Maternal Morbidity Composite
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
Measured: Randomization through 6 weeks postpartum
Length of Maternal Hospital Stay
Length of maternal hospital stay for the delivery admission (admission to discharge)
Measured: Delivery admission through discharge from the hospital (a median of 3 days)
Rate of Adverse Events of Special Interest (AESI) or Serious AESI
Adverse events of Special Interest (AESI) including myalgia and muscle weakness, and serious AESI include maternal myositis, myopathy, rhabdomyolysis, or serious liver injury
Measured: Randomization through 48 hours postpartum
Gestational Age at Delivery
Gestational age at the time of delivery
Measured: Delivery
Proportion of Participants With Preterm Birth < 37 Weeks
Preterm birth before 37 weeks gestation
Measured: Delivery before 37 weeks
Proportion of Participants With Indicated Preterm Birth < 37 Weeks
Indicated preterm birth less than 37 weeks
Measured: Delivery before 37 weeks
Proportion of Participants With Preterm Birth < 34 Weeks
Preterm birth before 34 weeks gestation
Measured: Delivery before 34 weeks
Proportion of Fetal or Neonatal Deaths
Death of the fetus or neonate
Measured: randomization (mother) through 28 days of life (neonate)
Birth Weight
Birth weight
Measured: Birth
Proportion of Small for Gestational Age < 5th Percentile
Birthweight < 5th percentile
Measured: Birth
Proportion of Small for Gestational Age < 10th Percentile
Birthweight < 10th percentile
Measured: Birth
Proportion of NICU/Intermediate Nursery Admission
Admission to the neonatal intensive care unit (NICU) or intermediate nursery
Measured: Birth through hospital discharge (an average of 4 days)
NICU/Intermediate Nursery Length of Stay
Length of stay in the neonatal intensive care unit (NICU) and/or intermediate nursery.
Measured: Birth through hospital discharge (an average of 4 days)
Proportion of Neonates Needing Mechanical Ventilation or Continuous Positive Airway Pressure (CPAP)
Mechanical ventilation or CPAP support
Measured: Birth through hospital discharge (an average of 4 days)
Proportion of Neonates Needing Oxygen Support
Provision of oxygen support for the neonate
Measured: Birth through hospital discharge (an average of 4 days)
Proportion of Neonates With Respiratory Distress Syndrome
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
Measured: Birth through hospital discharge (an average of 4 days)
Proportion of Neonates With Bronchopulmonary Dysplasia
Bronchopulmonary dysplasia (BPD), defined as oxygen requirement at 28 days of life and at 36 weeks corrected gestational age
Measured: 28 days of life and 36 weeks corrected gestational age
Proportion of Neonates With Necrotizing Enterocolitis
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)
Measured: Birth through hospital discharge (an average of 4 days)
Proportion of Neonates With Intraventricular Hemorrhage
Intraventricular hemorrhage (IVH) grade III-IV
Measured: Birth through hospital discharge (an average of 4 days)
Proportion of Neonates With Periventricular Leukomalacia (PVL)
Periventricular leukomalacia (PVL), diagnosed by neuroimaging
Measured: Birth through hospital discharge (an average of 4 days)
Proportion of Neonates Experiencing Early Onset Sepsis
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.
Measured: Birth to 72 hours from birth
Proportion of Neonates Experiencing Late Onset Sepsis
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.
Measured: Birth through hospital discharge (an average of 4 days)
Proportion of Neonates With Retinopathy of Prematurity
Retinopathy of prematurity (ROP) stage III or higher
Measured: Birth through hospital discharge (an average of 4 days)
Proportion of Neonates With Composite Neonatal Outcome
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
Measured: Birth through hospital discharge (an average of 4 days)
Proportion of Neonates Experiencing Seizures
Neonatal seizure activity
Measured: Birth through hospital discharge (an average of 4 days)
Proportion of Neonates With a Congenital Anomaly / Birth Defect
Congenital anomaly or birth defect excluding any conditions that must have been present before randomization
Measured: Randomization through delivery (up to approximately 30 weeks)
Neonatal Auditory Brain Stem Response (ABR)/Otoacoustic Emissions (OAE)
Neonatal auditory brain stem response (ABR)/Otoacoustic Emissions (OAE) test results of fail/refer.
Measured: Birth through hospital discharge (an average of 4 days)
BMI for Age at 24 Corrected Months
Body mass index for age percentile at 24 corrected months using Centers for Disease Control (CDC) pediatric growth charts
Measured: 24 months of age
Cognitive Standard Score From the Bayley Certified Scales of Infant Development III Edition at 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.
Measured: 24 months of age
Motor Standard Score From the Bayley Certified Scales of Infant Development III Edition at 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.
Measured: 24 months of age
Language Standard Score From the Bayley Certified Scales of Infant Development III Edition at 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.
Measured: 24 months of age
Gross Motor Function Classification System at 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)
Measured: 24 months of age
Proportion of Children With Hearing Loss at 24 Months of Age
Hearing loss at 24 months of age
Measured: 24 months of age
Child Behavior Checklist Total Problems T-Score at 24 Months
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.
Measured: 24 months of age
Proportion of Children With Vision Problems at 24 Months of Age
Vision problems (severe nearsightedness or farsightedness, and eye movement problems) at 24 months of age
Measured: 24 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start17 Jul 2019
- Primary completion6 Jun 2021
- Study completion20 Jun 2024
Why it stopped: participants are no longer being examined or receiving intervention
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a randomized controlled multi-center clinical trial of 1,550 women with a prior history of preeclampsia that required delivery at less than or equal to 34 weeks 0 days gestation, randomized to one of two arms at participating Maternal Fetal Medicine Units Network clinical centers. * 20 mg pravastatin daily * Identical appearing daily placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- The George Washington University Biostatistics Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Maged Costantine, MD, Principal investigator, Ohio State UniversityMonica Longo, MD, PHD, Study director, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Rebecca Clifton, PhD, Principal investigator, The George Washington University Biostatistics CenterVictoria Pemberton, RNC, MS, CCRC, Study director, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03944512
- Sponsor's protocol ID
- HD036801-Pravastatin
- Other IDs
- 5U10HD036801-20
- Acronym
- Pravastatin
- Status last verified
- Dec 2025
- First submitted
- 7 May 2019
- Last updated
- 23 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Given enrollment was limited to 50 participants, the dataset will not be shared.
Publications
Costantine MM, Cleary K, Hebert MF, Ahmed MS, Brown LM, Ren Z, Easterling TR, Haas DM, Haneline LS, Caritis SN, Venkataramanan R, West H, D'Alton M, Hankins G; Eunice Kennedy Shriver National Institute of Child Health and Human Development Obstetric-Fetal Pharmacology Research Units Network. Safety and pharmacokinetics of pravastatin used for the prevention of preeclampsia in high-risk pregnant women: a pilot randomized controlled trial. Am J Obstet Gynecol. 2016 Jun;214(6):720.e1-720.e17. doi: 10.1016/j.ajog.2015.12.038. Epub 2015 Dec 23.
PubMed 26723196
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Pravastatin to Prevent Preeclampsia in High Risk Women
- ClinicalTrials.gov ID
- NCT03944512
- Acronym / sponsor ID
- Pravastatin / HD036801-Pravastatin
- Keywords
- Pregnancy, Preeclampsia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: participants are no longer being examined or receiving intervention
- Enrolment
- 102 participants (actual)
- Lead sponsor
- The George Washington University Biostatistics CenterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 6 Jun 2021 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 9 May 2019 (actual)
- Results
- Posted 23 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a double-blind randomized placebo-controlled trial of 1,550 high-risk women to assess whether daily treatment with pravastatin administered early in pregnancy reduces the rate of a composite outcome of preeclampsia, fetal loss and maternal death. Women with a prior history of preeclampsia with preterm delivery less than 34 weeks will be randomized to pravastatin or placebo daily until delivery. Women will have monthly study visits during pregnancy, a follow-up visit at 6 weeks postpartum and children will have follow-up visits at 2 and 5 years of age.
Detailed description
Preeclampsia complicates approximately 3% to 5% of pregnancies and remains a major cause of maternal and neonatal morbidities and mortality. Women who experience preeclampsia in one pregnancy are at higher risk of developing preeclampsia in a subsequent pregnancy than those who have never experienced the condition. There is evidence from laboratory studies and clinical trials, as well as biological plausibility, to suggest that statins may prevent the development of preeclampsia by reversing various pathways associated with preeclampsia. Pravastatin has a favorable safety profile and pharmacokinetic properties.
The study is a randomized placebo-controlled multi-center clinical trial of 1,550 women with a prior history of preeclampsia that required delivery at less than 34 weeks, randomized to either 20mg pravastatin or an identical appearing placebo daily until delivery. Women with a singleton or twin gestation will be randomized between 12 weeks 0 days and 16 weeks 6 days will be followed monthly during pregnancy and then at 6 weeks postpartum. Children will have follow-up visits at 2 and 5 years of age to assess growth, cognition, behavior, motor skills, vision and hearing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study is a randomized controlled multi-center clinical trial of 1,550 women with a prior history of preeclampsia that required delivery at less than or equal to 34 weeks 0 days gestation, randomized to one of two arms at participating Maternal Fetal Medicine Units Network clinical centers. * 20 mg pravastatin daily * Identical appearing daily placebo
| Arm | Type | Receives |
|---|---|---|
| Pravastatin | Experimental | Drug: Pravastatin20 mg pravastatin daily |
| Placebo | Placebo comparator | Other: PlaceboIdentical appearing daily placebo |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 16 years or older at time of consent with ability to give informed consent
- Single or twin gestation with cardiac activity in one or both fetuses. Higher order multifetal gestations reduced to twins, either spontaneously or therapeutically, are not eligible unless the reduction occurred by 13 weeks 6 days project gestational age.
- Gestational age at randomization between 12 weeks 0 days and 16 weeks 6 days based on clinical information and evaluation of the earliest ultrasound.
- Documented history (by chart or delivery/operative note review) of prior preeclampsia with delivery less than or equal to 34 weeks 0 days gestation in any previous pregnancy. If in the index pregnancy, the woman was induced by 34 weeks 0 days gestation and delivered within 48 hours in the same hospitalization, that woman would be eligible.
- Normal serum transaminase (AST/ALT) concentrations documented in the last 6 months.
Key exclusion criteria (15 listed)
- Monoamniotic gestation because of the risk of fetal demise
- Known chromosomal, genetic or major malformations
- Fetal demise or planned termination of pregnancy. Selective reduction by 13 weeks 6 days gestation, from triplets to twins or twins to singleton is not an exclusion.
- Contraindications for statin therapy:
- Statin use in current pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pravastatin20 mg Pravastatin taken daily | Drug | Pravastatin |
| PlaceboIdentical appearing placebo pill | Other | Placebo |
Primary outcome
Proportion of Participants With Composite of Preeclampsia, Fetal Loss and Maternal Death
Time frame: 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
41 secondary outcomes
Proportion of Participants With Preeclampsia With Severe Features
Time frame: 48 hours postpartum
Proportion of Participants With Gestational Hypertension
Time frame: 48 hours postpartum
Proportion of Participants With Pregnancy Associated Hypertension
Time frame: 48 hours postpartum
Proportion of Participants With Postpartum Preeclampsia
Time frame: 48 hours postpartum through 6 weeks post partum
Proportion of Participants With Gestational Diabetes
Time frame: At any time during pregnancy through delivery (up to approximately 30 weeks)
Rate of Adherence to Study Medication
Time frame: Randomization to delivery (up to approximately 30 weeks)
Proportion of Participants With Severe Maternal Morbidity Composite
Time frame: Randomization through 6 weeks postpartum
Length of Maternal Hospital Stay
Time frame: Delivery admission through discharge from the hospital (a median of 3 days)
Rate of Adverse Events of Special Interest (AESI) or Serious AESI
Time frame: Randomization through 48 hours postpartum
Gestational Age at Delivery
Time frame: Delivery
Proportion of Participants With Preterm Birth < 37 Weeks
Time frame: Delivery before 37 weeks
Proportion of Participants With Indicated Preterm Birth < 37 Weeks
Time frame: Delivery before 37 weeks
Proportion of Participants With Preterm Birth < 34 Weeks
Time frame: Delivery before 34 weeks
Proportion of Fetal or Neonatal Deaths
Time frame: randomization (mother) through 28 days of life (neonate)
Birth Weight
Time frame: Birth
Proportion of Small for Gestational Age < 5th Percentile
Time frame: Birth
Proportion of Small for Gestational Age < 10th Percentile
Time frame: Birth
Proportion of NICU/Intermediate Nursery Admission
Time frame: Birth through hospital discharge (an average of 4 days)
NICU/Intermediate Nursery Length of Stay
Time frame: Birth through hospital discharge (an average of 4 days)
Proportion of Neonates Needing Mechanical Ventilation or Continuous Positive Airway Pressure (CPAP)
Time frame: Birth through hospital discharge (an average of 4 days)
Proportion of Neonates Needing Oxygen Support
Time frame: Birth through hospital discharge (an average of 4 days)
Proportion of Neonates With Respiratory Distress Syndrome
Time frame: Birth through hospital discharge (an average of 4 days)
Proportion of Neonates With Bronchopulmonary Dysplasia
Time frame: 28 days of life and 36 weeks corrected gestational age
Proportion of Neonates With Necrotizing Enterocolitis
Time frame: Birth through hospital discharge (an average of 4 days)
Proportion of Neonates With Intraventricular Hemorrhage
Time frame: Birth through hospital discharge (an average of 4 days)
Proportion of Neonates With Periventricular Leukomalacia (PVL)
Time frame: Birth through hospital discharge (an average of 4 days)
Proportion of Neonates Experiencing Early Onset Sepsis
Time frame: Birth to 72 hours from birth
Proportion of Neonates Experiencing Late Onset Sepsis
Time frame: Birth through hospital discharge (an average of 4 days)
Proportion of Neonates With Retinopathy of Prematurity
Time frame: Birth through hospital discharge (an average of 4 days)
Proportion of Neonates With Composite Neonatal Outcome
Time frame: Birth through hospital discharge (an average of 4 days)
Proportion of Neonates Experiencing Seizures
Time frame: Birth through hospital discharge (an average of 4 days)
Proportion of Neonates With a Congenital Anomaly / Birth Defect
Time frame: Randomization through delivery (up to approximately 30 weeks)
Neonatal Auditory Brain Stem Response (ABR)/Otoacoustic Emissions (OAE)
Time frame: Birth through hospital discharge (an average of 4 days)
BMI for Age at 24 Corrected Months
Time frame: 24 months of age
Cognitive Standard Score From the Bayley Certified Scales of Infant Development III Edition at 24 Months of Age
Time frame: 24 months of age
Motor Standard Score From the Bayley Certified Scales of Infant Development III Edition at 24 Months of Age
Time frame: 24 months of age
Language Standard Score From the Bayley Certified Scales of Infant Development III Edition at 24 Months of Age
Time frame: 24 months of age
Gross Motor Function Classification System at 24 Months of Age
Time frame: 24 months of age
Proportion of Children With Hearing Loss at 24 Months of Age
Time frame: 24 months of age
Child Behavior Checklist Total Problems T-Score at 24 Months
Time frame: 24 months of age
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26723196Costantine MM, Cleary K, Hebert MF, Ahmed MS, Brown LM, Ren Z, Easterling TR, Haas DM, Haneline LS, Caritis SN, Venkataramanan R, West H, D'Alton M, Hankins G; Eunice Kennedy Shriver National Institute of Child Health and Human Development Obstetric-Fetal Pharmacology Research Units Network. Safety and pharmacokinetics of pravastatin used for the prevention of preeclampsia in high-risk pregnant women: a pilot randomized controlled trial. Am J Obstet Gynecol. 2016 Jun;214(6):720.e1-720.e17. doi: 10.1016/j.ajog.2015.12.038. Epub 2015 Dec 23.
- Individual participant dataSharing planned: Yes. Given enrollment was limited to 50 participants, the dataset will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maged Costantine, MD principal investigator
Ohio State University
Monica Longo, MD, PHD study director
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Rebecca Clifton, PhD principal investigator
The George Washington University Biostatistics Center
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pravastatin in people with Preeclampsia and Obstetric Labor Complications, run by The George Washington University Biostatistics Center at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With Composite of Preeclampsia, Fetal Loss and Maternal Death (time frame: 48 hours postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03944512, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.