Pravastatin for Preeclampsia Prevention

(Statin Trial)

Recruiting at 2 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: The University of Texas Medical Branch, Galveston

Must not be taking: Statins, Cyclosporine, Fibrates, others

Disqualifiers: HIV, Cancer, Renal disease, others

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 30 weeks

48 Participants Needed

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.

Research Team

Maged Costantine, MD

Principal Investigator

UTexasGalveston; Ohio State

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pravastatin or placebo daily during pregnancy to evaluate safety and pharmacokinetics

Up to 30 weeks

Regular visits for monitoring adverse events and pharmacokinetic sampling

Follow-up

Participants are monitored for maternal and fetal adverse events until delivery and up to 120 days postpartum

Up to 120 days postpartum

Post-delivery visits for monitoring neonatal outcomes

Treatment Details

Interventions

• Placebo
• Pravastatin

Trial Overview 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.

Participant Groups

Group I: Pravastatin Group Active Control 1 Intervention

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

Group II: Control Group Placebo Group 1 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:

• High Cholesterol
• Hyperlipoproteinemia
• Myocardial Infarction - Prophylaxis
• Revascularization Procedures - Prophylaxis

Approved in European Union as Pravastatin for:

• Hypercholesterolaemia
• Mixed dyslipidaemia
• Prevention of cardiovascular events

Approved in Canada as Pravastatin for:

• Hypercholesterolemia
• Mixed dyslipidemia
• Prevention of cardiovascular events

Approved in Japan as Pravastatin for:

• Hypercholesterolemia
• Familial hypercholesterolemia

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials

263

Recruited

55,400+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+