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

RecruitingPhase 2Ages 18 Years - anyFemaleFundació Institut de Recerca de l'Hospital de la …
NCT07098975 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

In pregnancies with placental insufficiency, the only available treatment is close monitoring to determine the point at which the risks of preterm birth for the baby are lower than the risks of continuing the pregnancy. Therefore, safely prolonging pregnancy is the current management goal for this condition. Statins, such as pravastatin, are approved and marketed drugs used to prevent cardiovascular disease. Recent studies suggest that statins may help treat pregnancy complications and prolong pregnancy, thereby avoiding extreme prematurity and improving long-term health outcomes for both mother and baby. Previous clinical trials have shown the ability of statins to stabilize angiogenic factors, thus reducing obstetric complications associated with placental insufficiency. In 2015, a study reported that pravastatin was effective in stabilizing blood pressure and reducing proteinuria as

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📋 Eligibility rules (as published)
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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What it tests

  • Pravastatin 40 mg
  • Placebo
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Where

2 sites
Hospital de la Santa Creu i de Sant Pau
Barcelona, Spain
Hospital Clínic de Barcelona
Barcelona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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