The Effectiveness of Cerclage for the Reduction of Extreme Preterm Birth and Perinatal Mortality in Twin Pregnancies With a Short Cervix or Dilatation

What this Trial Is About

This trial investigates the effectiveness of vaginal cerclage compared to standard treatment in women with twin pregnancies who have a short cervix or cervical dilatation in midpregnancy. The study focuses on preventing extreme preterm birth before 28 weeks of gestation, a serious concern due to high rates of perinatal death in this group. The research aims to provide evidence on whether cerclage can reduce early births and improve outcomes for babies and families. Participants will be randomly assigned to receive either a vaginal cerclage or standard care without cerclage. The cerclage procedure involves placing an unabsorbable suture around the cervix under anesthesia to strengthen and close it, aiming to prevent cervical insufficiency. The comparison group will follow current Dutch guidelines, which do not include cerclage for this condition. During the study, participants will be monitored for preterm birth rates and various maternal and neonatal health outcomes up to three months after birth. Assessments include gestational age at delivery, days on ventilation and in neonatal intensive care, maternal quality of life, and adverse events. The primary measure is the rate of extreme preterm birth before 28 weeks. The trial will continue until December 2028, with ongoing evaluation of both short-term and longer-term effects.

Cerclage for the Reduction of Extreme Preterm Birth in Twin Pregnancies With a Short Cervix or Dilatation