Daily Pravastatin Treatment to Prolong Pregnancy in Severe Early-Onset Placental Insufficiency with Preeclampsia or Growth Restriction

What this Trial Is About

Researchers are studying the use of pravastatin to help women with placental insufficiency, a condition that can cause serious pregnancy complications like preeclampsia PE and intrauterine growth restriction IUGR. These conditions increase risks for both mother and baby, often leading to premature birth. Current management focuses on closely monitoring the pregnancy to decide the safest time for delivery. This Phase 2 trial aims to see if daily pravastatin can safely extend pregnancy duration and improve heart health for mothers and babies. Participants will receive either 40 mg of pravastatin daily or a matching placebo starting between 24 and 29.6 weeks of pregnancy until delivery, usually for about 4 weeks but up to 10 weeks. The study is randomized and double-blinded, meaning neither participants nor healthcare providers know who receives the active drug. Researchers will compare outcomes between the two groups to understand if pravastatin helps prolong pregnancy and supports cardiovascular function. During the study, mothers will be monitored through pregnancy and delivery, with heart and blood vessel ultrasounds and blood tests performed on mothers and babies six months after birth. Researchers will also follow up annually by phone for up to four years to check on ongoing health and safety. The main measurement is how many days pregnancy lasts after starting the study drug or placebo. Additional outcomes include birth weight, neonatal health, and heart function. The study plans to enroll 154 pregnant women with severe early-onset placental insufficiency.

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