Pravastatin for severe early-onset placental insufficiency

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hospital de la Santa Creu i de Sant Pau
  Barcelona, Barcelona, Spain Recruiting
• Hospital Clínic de Barcelona
  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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.