Study Comparing Early Delivery at 35 Weeks Versus Later Delivery at 38 Weeks for Pregnant Women with Gastroschisis

What this Trial Is About

Gastroschisis is a common birth defect where the intestines develop outside the babys body. This trial evaluates whether delivering babies with stable gastroschisis at 35 weeks is better than waiting for delivery at 38 weeks. The study aims to find out which timing reduces risks like stillbirth, early death, breathing problems, and need for special nutrition. It is a multi-center, randomized trial across several institutions affiliated with NAFTNet. Participants are randomly assigned at 33 weeks to either have delivery induced between 35 07 and 35 67 weeks or to be observed and delivered between 38 07 and 38 67 weeks. The study compares these two strategies to see which leads to better outcomes for the baby. Secondary outcomes include delivery complications, maternal health issues, and detailed prenatal test results, along with various newborn health measures such as birth weight and infection rates. During the trial, participants will be closely monitored from consent until the infants discharge from the neonatal intensive care unit, which may last up to 30 weeks depending on recovery. Researchers will collect data on fetal health, delivery details, and newborn progress. Blood samples from newborns will be stored for future research. The trial will build a large database to support further study of gastroschisis outcomes in the United States.

Gastroschisis Outcomes of Delivery (GOOD) Study