Prevent-PE (pre-eclampsia prevention by timed birth at term): Protocol for a randomised trial.

Area of Science:

• Obstetrics and Gynecology
• Maternal-Fetal Medicine
• Clinical Trial Research

Background:

• Pre-eclampsia (PE) is a significant cause of maternal and neonatal morbidity.
• Current management often involves expectant care until term, with potential for adverse outcomes.

Purpose of the Study:

• To assess if screening for term pre-eclampsia (PE) risk between 35 and 36 weeks' gestation, coupled with risk-based planned early term birth, reduces PE incidence.
• To evaluate the effectiveness and cost-effectiveness of a risk-based intervention for term PE.

Main Methods:

• The PREVENT-PE study is a multicentre, randomized controlled trial comparing an intervention group (PE risk screening and planned early birth) with a control group (usual care).
• Participants are singleton pregnancies presenting for routine ultrasound between 35+0 and 36+6 weeks' gestation.
• Randomization is 1:1, with planned sample sizes of 4000-8000 participants, using an adaptive design.

Main Results:

• The primary outcome is birth with pre-eclampsia (PE) based on ISSHP 2021 criteria.
• Secondary outcomes include emergency cesarean delivery and neonatal unit admission for ≥48 hours.
• Economic evaluations will assess cost-effectiveness and cost-utility from a health service perspective.

Conclusions:

• The PREVENT-PE trial is expected to provide crucial data on the benefits and costs of a proactive, risk-based approach to managing term pre-eclampsia.
• Findings will inform clinical decision-making regarding birth timing and maternity service provision for pregnancies at risk of PE.