A Randomized Controlled Trial of Pravastatin to Prevent Preeclampsia in High Risk Women

Who is this study for? Women at high risk for preeclampsia
What treatments are being studied? Pravastatin
Status: Terminated
Location: See all (12) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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. 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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 16
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
University of Alabama - Birmingham
Birmingham
Illinois
Northwestern University
Chicago
North Carolina
University of North Carolina - Chapel Hill
Chapel Hill
New York
Columbia University
New York
Ohio
Case Western Reserve-Metro Health
Cleveland
Ohio State University Hospital
Columbus
Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia
Magee Women's Hospital of UPMC
Pittsburgh
Rhode Island
Brown University
Providence
Texas
University of Texas Medical Branch
Galveston
University of Texas - Houston
Houston
Utah
University of Utah Medical Center
Salt Lake City
Time Frame
Start Date: 2019-07-17
Completion Date: 2024-06-20
Participants
Target number of participants: 50
Treatments
Experimental: Pravastatin
20 mg pravastatin daily
Placebo_comparator: Placebo
Identical appearing daily placebo
Related Therapeutic Areas
Sponsors
Leads: The George Washington University Biostatistics Center
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov