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Cholesterol drug tested to stop dangerous pregnancy complication

NCT ID NCT03944512

Prevention Sponsor: The George Washington University Biostatistics Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether the cholesterol-lowering drug pravastatin could prevent preeclampsia in women who had a previous early preterm delivery due to the condition. The trial planned to enroll 1,550 women but was terminated early with only 102 participants. Because it stopped early, the results are not strong enough to draw clear conclusions about whether pravastatin helps or is safe in pregnancy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pravastatin (a statin drug, typically used for cholesterol)
What this could lead to
If it had worked, this could have pointed toward a way to prevent preeclampsia in women at high risk, potentially saving lives and preventing complications.
What could go wrong
The trial was terminated early with only 102 participants instead of the planned 1,550, so results are very limited and not reliable. Statins are generally not recommended in pregnancy due to safety concerns.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

102 people

The number who actually took part.

Started

Jul 2019

Finished

Jun 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 16 years or older at time of consent with ability to give informed consent 2. Single or twin gestation with cardiac activity in one or both fetuses. Higher order multifetal gestations reduced to twins, either spontaneously or therapeutically, are not eligible unless the reduction occurred by 13 weeks 6 days project gestational age. 3. Gestational age at randomization between 12 weeks 0 days and 16 weeks 6 days based on clinical information and evaluation of the earliest ultrasound. 4. Documented history (by chart or delivery/operative note review) of prior preeclampsia with delivery less than or equal to 34 weeks 0 days gestation in any previous pregnancy. If in the index pregnancy, the woman was induced by 34 weeks 0 days gestation and delivered within 48 hours in the same hospitalization, that woman would be eligible. 5. Normal serum transaminase (AST/ALT) concentrations documented in the last 6 months. Exclusion Criteria: 1. Monoamniotic gestation because of the risk of fetal demise 2. Known chromosomal, genetic or major malformations 3. Fetal demise or planned termination of pregnancy. Selective reduction by 13 weeks 6 days gestation, from triplets to twins or twins to singleton is not an exclusion. 4. Contraindications for statin therapy: 1. Hypersensitivity to pravastatin or any component of the product 2. Active liver disease: acute hepatitis or chronic active hepatitis 5. Statin use in current pregnancy 6. Patients with any of the following medical conditions: 1. Uncontrolled hypothyroidism with a TSH level above 10 mIU/L, because of increased risk of myopathy 2. HIV positive, because of increased risk of myopathy with use of protease inhibitors 3. Chronic renal disease with baseline serum creatinine ≥1.5 mg/dL, because of association with adverse pregnancy outcomes 7. Current use of concomitant medication with potential for drug interaction with statins (i.e.,, cyclosporine, fibrates, niacin, erythromycin). Patients will not be excluded if the drug is discontinued (at least one week) prior to randomization. 8. Participating in another intervention study that influences the primary outcome in this study 9. Plan to deliver in a non-network site 10. Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, do not have to be excluded.

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Conditions

The condition(s) this trial relates to.

hypertension, pregnancy-induced Obstetric Labor Complications preeclampsia prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypertension in pregnancy Obstetric labor complications Preeclampsia

Contacts and locations

Locations

  • Brown University

    Providence, Rhode Island, 02905, United States

  • Case Western Reserve-Metro Health

    Cleveland, Ohio, 44109, United States

  • Columbia University

    New York, New York, 10032, United States

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Magee Women's Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Ohio State University Hospital

    Columbus, Ohio, 43210, United States

  • University of Alabama - Birmingham

    Birmingham, Alabama, 35233, United States

  • University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • University of Texas - Houston

    Houston, Texas, 77030, United States

  • University of Texas Medical Branch

    Galveston, Texas, 77555, United States

  • University of Utah Medical Center

    Salt Lake City, Utah, 84132, United States

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