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HMG-CoA Reductase Inhibitor
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of randomization until the date of delivery, assessed up to 210 days
Awards & highlights
Statin Trial 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.Check my eligibility
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.See study design
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.
Statin Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had a severe pregnancy complication early and delivered before 34 weeks in a past pregnancy.
Statin Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number and type of fetal/neonatal adverse events
Number and type of maternal adverse events
Pharmacokinetic parameters of pravastatin sodium during pregnancy
Statin Trial Design
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.
Find a Location
Who is running the clinical trial?
The University of Texas Medical Branch, GalvestonLead Sponsor
241 Previous Clinical Trials
56,550 Total Patients Enrolled
University of PittsburghOTHER
1,719 Previous Clinical Trials
16,342,293 Total Patients Enrolled
Northwestern UniversityOTHER
1,585 Previous Clinical Trials
917,183 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.I am currently pregnant and taking statins or medications that may interact with them.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.I am over 18 and can give my consent.I am willing to attend all scheduled visits for the drug study.I have a condition like HIV, had an organ transplant, kidney disease, uterine issues, or cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Pravastatin Group
- Group 2: Control Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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