Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial)

Plain-language summary

This study evaluates the effect of the drug Pravastatin, compared with a placebo, in severe early-onset placental insufficiency (when the placenta cannot nourish the baby adequately). It can include pregnant women with a single fetus who, between 24 and 30 weeks of pregnancy, have been diagnosed with early-onset severe preeclampsia and/or intrauterine growth restriction (IUGR). The study is in Phase 2 and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Recruiting

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Intervention

Pravastatin 40 mg, Placebo

Start date

1/14/2026

Estimated completion

7/1/2028

Countries

Spain

Related genes

Locations

• Barcelona, Spain
• Barcelona, Spain

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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