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Pravastatin to Prevent Preeclampsia

NCT03944512 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2025-12-23

Study results available
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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.

Conditions

  • Preeclampsia
  • Obstetric Labor Complications
  • Hypertension in Pregnancy

Interventions

DRUG

Pravastatin

20 mg Pravastatin taken daily

OTHER

Placebo

Identical appearing placebo pill

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • The George Washington University Biostatistics Center

    lead OTHER

Principal Investigators

  • Maged Costantine, MD · Ohio State University

  • Monica Longo, MD, PHD · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  • Rebecca Clifton, PhD · The George Washington University Biostatistics Center

  • Victoria Pemberton, RNC, MS, CCRC · National Heart, Lung, and Blood Institute (NHLBI)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-17
Primary Completion
2021-06-06
Completion
2024-06-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03944512 on ClinicalTrials.gov