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Could a statin help save babies from early delivery?

NCT ID NCT07098975

Disease control Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a daily dose of pravastatin, a common heart medication, can safely prolong pregnancy in women diagnosed with severe early-onset preeclampsia or fetal growth restriction. The trial will include 154 pregnant women between 24 and 30 weeks of gestation, randomly assigned to receive either pravastatin or a placebo. The goal is to see if the drug can delay delivery and improve outcomes for both mother and baby.

What this could mean

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

Active substance
Pravastatin 40 mg
What this could lead to
If it works, this could offer a way to safely prolong pregnancy in women with placental insufficiency, reducing complications from early delivery.
What could go wrong
This is a Phase 2 trial with only 154 participants, so results are preliminary. Statins are generally safe but not yet proven for this use in pregnancy.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 154 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jul 2028

An estimate. End dates often move.

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

18 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: * Singleton fetus. * Between 24+0 to 29+6 weeks of gestation at the inclusion. * Early-onset severe PE: women with a diagnosis of severe-preterm PE who are candidates for expectant management and have no clinical indication for immediate delivery, based on the clinical assessments of the attending doctors. And/or * IUGR: Diagnosis of early onset IUGR according to the SMFM classification with umbilical artery Doppler with absent/reversed diastolic flow; or estimated fetal weight \<10th percentile plus pulsatility index (PI) of umbilical artery Doppler \>95th percentil. * Able to give informed consent. Exclusion Criteria: * Established maternal or fetal compromise that necessitated immediate delivery * Abnormal karyotype, structural abnormalities, or congenital infections. * Treatment with pravastatin or other statins prior to inclusion. * Lactose intolerance

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Conditions

The condition(s) this trial relates to.

fetal growth restriction placental insufficiency preeclampsia

As listed by the trial registrant

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

Intrauterine growth restriction (IUGR) Placental insufficiency Preeclampsia (PE)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Clínic de Barcelona

    NOT_YET_RECRUITING

    Barcelona, Spain

  • Hospital de la Santa Creu i de Sant Pau

    RECRUITING

    Barcelona, 08025, Spain

More trials for these conditions

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