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

Launched by FUNDACIÓ INSTITUT DE RECERCA DE L'HOSPITAL DE LA SANTA CREU I SANT PAU · Feb 19, 2021

Keywords

ClinConnect Summary

This clinical trial aims to find a better way to predict and prevent a serious condition called preeclampsia (PE) in pregnant women. Preeclampsia can occur in about 5% of pregnancies and is a leading cause of complications for both mothers and babies. The researchers want to see if a specific blood test, which measures the levels of certain proteins (sFlt1 and PlGF), can help identify women at high risk for term PE around 35-37 weeks of pregnancy. If the test shows a high risk, these women may be offered to have labor induced starting at 37 weeks, which has been shown to be safe. The goal is to reduce the occurrence of term PE without increasing the chances of cesarean sections or harming newborns.

To participate in this trial, women must be first-time mothers (nulliparous), at least 18 years old, and between 35-36 weeks pregnant with a single baby. Women who have certain pregnancy complications or are part of other studies that might affect delivery timing cannot join. Participants will be randomly assigned to either a group where their test results are known to the doctors or a group where the results are kept secret. This trial could lead to a simple and effective screening method that could be used widely, improving pregnancy outcomes and healthcare policies around the world.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Nulliparous women
• • Singleton pregnancies
• • \>18 years old
• • 35.0-36.6 weeks of gestation
• • Maternal written consent form
• Exclusion Criteria:
• • Fetuses/neonates with major malformations or genetic anomalies that could modify the timing of delivery or has an impact on obstetric outcome
• • Suspected fetal growth restriction (estimated fetal weight \<3 centile or between the 3rd and 10th centile together with abnormal Doppler in the mean uterine artery Doppler pulsatility index, or in umbilical artery pulsatility index or in the middle cerebral artery or in the cerebral umbilical index (CPR))
• • Participation in another interventional study that could modify the timing of delivery.