Protocol of the PE37 Study: A Multicenter Randomized Trial of Screening With sFlt1/PlGF and Planned Delivery to Prevent Preeclampsia at Term

What this Trial Is About

Preeclampsia (PE) affects about 5% of pregnancies and remains a major cause of illness and death for mothers worldwide. Term PE, which occurs at or after 37 weeks, accounts for 70% of all PE cases and leads to significant health risks for mothers and babies. Researchers are studying whether a simple blood test screening using the sFlt1/PlGF ratio at 35 to 37 weeks, followed by planned induction of labor (IOL) from 37 weeks in high-risk women, can reduce the occurrence of term PE without increasing cesarean deliveries or harming newborns. The study compares two groups of first-time pregnant women: one group will have their sFlt1/PlGF ratio results revealed to doctors and receive an offer of induction from 37 weeks if their risk is high (above the 90th percentile), while the other group will have their results concealed and receive routine care. The screening test is a single-step blood test done between 35.0 and 36.6 weeks. Induction of labor is planned only for those with a high-risk test result in the revealed group. The other group will continue with standard pregnancy follow-up and spontaneous delivery. Participants will be monitored for the development of term PE and other maternal and newborn health outcomes for up to 6 months after delivery. Researchers will assess rates of term PE within 4 weeks, cesarean section rates, maternal and neonatal hospital stays, maternal complications, perinatal complications, maternal experience, and cardiovascular risk post-delivery. The study involves regular follow-up visits and data collection to evaluate the effectiveness and safety of the screening and intervention strategy.

sFlt1/PlGF and Planned Delivery to Prevent Preeclampsia at Term.