Evaluating First-Trimester Screening for Preeclampsia Using the FMF Triple Test and Aspirin Treatment to Improve Maternal and Newborn Health

What this Trial Is About

Researchers are evaluating whether screening for preeclampsia in the first trimester of pregnancy using the FMF algorithm improves health outcomes for mothers and their babies. Preeclampsia affects 2% of pregnancies and can cause serious complications. This study aims to provide strong evidence on the benefits, risks, and costs of early screening combined with aspirin treatment for those identified at risk. The study compares two groups of pregnant women between 11 and 14 weeks gestation. One group receives the FMF triple test, which includes maternal factors, blood pressure, uterine artery Doppler, and blood markers PlGF. Women at high risk are prescribed aspirin daily from early pregnancy until 36 weeks. The other group receives usual prenatal care without preeclampsia screening. Screening and treatment are integrated into routine first-trimester care. Participants will complete questionnaires about satisfaction and anxiety during pregnancy and after delivery. Researchers will monitor severe perinatal morbidity, including stillbirth, early birth before 34 weeks, and very low birth weight. They will also assess preeclampsia rates, maternal health complications, aspirin side effects, healthcare use, and costs. The study will track participants until about 30 days after delivery to evaluate the impact of screening on health and well-being.

Impact of First-trimester Preeclampsia Screening on Perinatal and Maternal Morbidity (RANSPRE)