Pravastatin for Preeclampsia Prevention (Statin Trial)

Phase 1

Waitlist Available

Led By Maged Costantine, MD

Research Sponsored by The University of Texas Medical Branch, Galveston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented history of prior severe early onset PE in a prior pregnancy and requiring delivery ≤340/7 weeks' gestation

Be older than 18 years old

Must not have

Known chromosomal, genetic, or major fetal malformations, fetal demise, or planned termination

Contraindications for statin therapy including hypersensitivity to pravastatin, active liver disease, history of myopathy or rhabdomyolysis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of randomization until the date of delivery, assessed up to 210 days

Summary

This trial will study how safe and effective pravastatin is as a daily treatment for pregnant women at high risk for preeclampsia.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Pravastatin may cause side effects such as muscle pain or weakness (myopathy), serious muscle injury (rhabdomyolysis), liver problems, and increased blood sugar levels. Pregnant women are closely monitored due to potential risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

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

Select...

I am currently pregnant and taking statins or medications that may interact with them.

Select...

I have a condition like HIV, had an organ transplant, kidney disease, uterine issues, or cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of randomization until the date of delivery, assessed up to 210 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of randomization until the date of delivery, assessed up to 210 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of randomization until the date of delivery, assessed up to 210 days for reporting.