Clinical Trial: Gastroschisis Outcomes of Delivery (GOOD) Study

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional




Official Title: Gastroschisis Outcomes of Delivery (GOOD) Study

Brief Summary: The objective of this study is to investigate the hypothesis that delivery at 36 0/7- 36 6/7 weeks in stable patients with gastroschisis is superior to observation and expectant management. To test this hypothesis, we will complete a randomized, prospective, multi-institutional trial across North American Fetal Therapy Network-affiliated institutions. Patients may be enrolled in the study any time prior to 34 weeks, but will be randomized at 34 weeks to delivery at 36 weeks or observation. The primary composite outcomes will include stillbirth, neonatal death prior to discharge, respiratory morbidity, and need for parenteral nutrition at 30 days.