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Pravastatin for Preeclampsia (Pravastatin Trial)
Pravastatin Trial Summary
This trial will test whether pravastatin can reduce the rate of preeclampsia, fetal loss and maternal death in high-risk women.
Pravastatin Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPravastatin Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2013 Phase 4 trial • 252 Patients • NCT01301066Pravastatin Trial Design
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Who is running the clinical trial?
Media Library
- If you are pregnant, you are only eligible if you are carrying one or two babies and if any reduction of more than two babies occurred before 14 weeks of pregnancy.You have uncontrolled hypothyroidism, HIV, chronic kidney disease, or are taking certain medications that could interact with the study drug. You are also excluded if you are involved in another study that could affect the results, plan to give birth at a non-network site, or have previously participated in this trial during a past pregnancy.I am 16 or older and can make my own medical decisions.I am not allergic to pravastatin, do not have active liver disease, and am not pregnant.Your liver enzymes (AST/ALT) should be at normal levels based on a blood test taken within the last 6 months.You are pregnant with twins sharing the same amniotic sac, which can be risky for the babies.If you had a serious condition called preeclampsia and delivered a baby before 34 weeks in a past pregnancy, you may not be eligible. But if you were induced at 34 weeks and delivered within 48 hours during the same hospital stay, you may be eligible.I have a known genetic condition or major birth defect.
- Group 1: Pravastatin
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
What is the participant count for this experiment?
"Although this trial is no longer active, it is worth noting that there are 115 clinical trials for obstetric labor complications and 12 for Pravastatin that are currently looking for participants."
What are some other similar studies to this one that have been done in the past?
"Pravastatin has been researched since 2009 by Eiger BioPharmaceuticals. The first trial, involving 85 patients, completed in 2009. Pravastatin received its Phase 2 drug approval following the first trial in 2009. As of now, there are 12 live studies for Pravastatin being conducted across 45 cities and 11 countries."
What are some of Pravastatin's most popular applications?
"Pravastatin is frequently used in secondary prevention and has additional benefits for treating cardiovascular disease, low-density lipoproteins, and coronary heart disease."
What other scientific research has been undertaken to explore Pravastatin's medical benefits?
"Pravastatin was first investigated in 2009 at Children's Hospital Boston. To date, there have been 18320 completed clinical trials and there are presently 12 live trials. A large concentration of these trials are being conducted in Chicago, Illinois."
Has Pravastatin been cleared by the FDA?
"Pravastatin is considered safe and was given a score of 3. This is because there is some data supporting efficacy and multiple rounds of data supporting safety."
In how many medical facilities is this research project being conducted?
"In addition to locations at Northwestern University, Columbia University, and Brown University, this trial is also being conducted at 11 other sites across the country."
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