- Solid Tumors
- Pipeline Molecules
- Alliance Partners
Our mission is to provide healthcare professionals with unbiased clinical research information, easily.
Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03944512
Recruitment Status Recruiting
First Posted May 9, 2019
Last update posted July 20, 2020
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.
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.
20 mg pravastatin daily
20 mg Pravastatin taken daily
|Placebo Comparator: Placebo
Identical appearing daily placebo
Identical appearing placebo pill
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
1. 16 years or older at time of consent with ability to give informed consent
2. 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.
3. Gestational age at randomization between 12 weeks 0 days and 16 weeks 6 days based on
clinical information and evaluation of the earliest ultrasound.
4. 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
5. Normal serum transaminase (AST/ALT) concentrations documented in the last 6 months.
1. Monoamniotic gestation because of the risk of fetal demise
2. Known chromosomal, genetic or major malformations
3. 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.
4. Contraindications for statin therapy:
1. Hypersensitivity to pravastatin or any component of the product
2. Active liver disease: acute hepatitis or chronic active hepatitis
5. Statin use in current pregnancy
6. Patients with any of the following medical conditions:
1. Uncontrolled hypothyroidism with a TSH level above 10 mIU/L, because of increased
risk of myopathy
2. HIV positive, because of increased risk of myopathy with use of protease
3. Chronic renal disease with baseline serum creatinine ≥1.5 mg/dL, because of
association with adverse pregnancy outcomes
7. 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.
8. Participating in another intervention study that influences the primary outcome in
9. Plan to deliver in a non-network site
10. 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.
Contact: Rebecca Clifton, PhD 301-881-9260 email@example.com
Contact: Trisha Boekhoudt 301-881-9260 firstname.lastname@example.org
United States, Alabama
University of Alabama - Birmingham
United States, Illinois
United States, New York
United States, North Carolina
University of North Carolina - Chapel Hill
United States, Ohio
Case Western Reserve-Metro Health
United States, Ohio
Ohio State University Hospital
United States, Pennsylvania
Hospital of the University of Pennsylvania
United States, Pennsylvania
Magee Women's Hospital of UPMC
United States, Rhode Island
United States, Texas
University of Texas Medical Branch
United States, Texas
University of Texas - Houston
United States, Utah
University of Utah Medical Center
Salt Lake City
The George Washington University Biostatistics Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Heart, Lung, and Blood Institute (NHLBI)
Study Chair: Maged Costantine, MD University of Texas
Study Director: Andrew Bremer, MD, PhD, MAS Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Rebecca Clifton, PhD The George Washington University Biostatistics Center
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.