Pravastatin for severe early-onset placental insufficiency
Statin Intervention for Severe Early-Onset Placental Insufficiency: A Randomized Controlled Trial Assessing Daily Administration as a Treatment Strategy (STATIN-PRE Trial)
This trial will test whether pravastatin can safely prolong pregnancy and lower risks for pregnant people with severe early-onset preeclampsia or early-onset IUGR between 24+0 and 29+6 weeks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 154 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Academic / other |
| Locations | 2 sites (Barcelona and 1 other locations) |
| Trial ID | NCT07098975 on ClinicalTrials.gov |
What this trial studies
This phase 2 interventional trial gives eligible pregnant participants either pravastatin 40 mg or a matching placebo and follows them until delivery to track pregnancy length and maternal and neonatal outcomes. Enrollment targets people with a singleton pregnancy and either severe early-onset preeclampsia who are candidates for expectant management or early-onset IUGR with abnormal umbilical artery Dopplers, between 24+0 and 29+6 weeks. The protocol includes close in-person monitoring of maternal vital signs, fetal growth and Doppler studies, and laboratory markers including angiogenic factors. The main goal is to see if pravastatin can safely reduce the need for very early delivery and lower prematurity-related complications.
Who should consider this trial
Good fit: Ideal candidates are pregnant people with a singleton fetus at 24+0 to 29+6 weeks who have severe early-onset preeclampsia eligible for expectant management or early-onset IUGR with abnormal umbilical artery Doppler and who can give informed consent.
Not a fit: People with immediate maternal or fetal compromise requiring delivery, major fetal anomalies or abnormal karyotype or infections, prior statin treatment, or lactose intolerance are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If effective, pravastatin could safely prolong pregnancy, reduce extreme prematurity, and improve short- and long-term health outcomes for both mother and baby.
How similar studies have performed: Previous small trials and studies have suggested that pravastatin can stabilize angiogenic markers and may reduce some complications of preeclampsia, but large definitive randomized evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Barcelona and 1 other locations
- Hospital de la Santa Creu i de Sant Pau — Barcelona, Spain (Recruiting)
- Hospital Clínic de Barcelona — Barcelona, Spain (Not_yet_recruiting)
Study contacts
- Study coordinator: Elisa Llurba Olivé, Doctor
- Email: ellurba@santpau.cat
- Phone: +34 93 553 70 48/ 93 553 70 41
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.