Pravastatin for Preeclampsia Prevention
(Statin Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byMaged Costantine, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: The University of Texas Medical Branch, Galveston

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?The primary purpose of this pilot study is to determine the pharmacokinetic (PK) parameters and collect preliminary safety data for pravastatin when used as a prophylactic daily treatment in pregnant women at high risk of preeclampsia.

Eligibility Criteria

This trial is for pregnant women aged 18 or older at high risk of severe early onset preeclampsia, with a single pregnancy between 12 and nearly 17 weeks along. They must have normal liver function and be willing to attend study visits. Women can't join if they have certain health conditions like active liver disease, kidney issues, HIV, or are using drugs that interact badly with statins.

Inclusion Criteria

Normal serum transaminase concentrations in the last 6 months

I had a severe pregnancy complication early and delivered before 34 weeks in a past pregnancy.

I was induced into labor at 34 weeks of pregnancy and delivered within 48 hours.

+4 more

Exclusion Criteria

Participating in another intervention study that influences the outcomes of this study, plans to deliver in a non-network site

My pregnancy does not have known major genetic issues or malformations.

I am allergic to pravastatin, have active liver disease, or a history of muscle issues.

+2 more

Participant Groups

The study is testing whether pravastatin can prevent preeclampsia in high-risk pregnant women. Participants will either receive pravastatin daily or a placebo (a pill without the drug). The team will measure how the body processes the drug and monitor safety.

2Treatment groups

Active Control

Placebo Group

Group I: Pravastatin GroupActive Control1 Intervention

Pregnant women at high-risk for preeclampsia who are taking pravastatin during their pregnancy.

Group II: Control GroupPlacebo Group1 Intervention

Pregnant women who are at high-risk for developing preeclampsia who are taking a placebo during their pregnancy.

Pravastatin is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Pravachol for: