Phase 2Recruiting
Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial)
Statin Intervention for Severe Early-Onset Placental Insufficiency: A Randomized Controlled Trial Assessing Daily Administration as a Treatment Strategy (STATIN-PRE Trial)
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Academic or other)
- Enrolment
- 154 planned
- Conditions
- Preeclampsia (PE); Intrauterine Growth Restriction (IUGR); Placental Insufficiency
- Interventions
- Pravastatin 40 mg; Placebo
- Ages
- adults, older adults
- Registry
- NCT07098975
Full record on ClinicalTrials.gov
From the registry
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 associated with preeclampsia. More recently, in 2020, it was demonstrated that in pregnant women with fetal growth restriction treated with pravastatin, the sFlt-1/PlGF ratio was lower than in…
Primary outcomes
- Days of prolongation of pregnancy between inclusion and delivery.
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered