Gastroschisis Outcomes of Delivery (GOOD) Study
The objective of this study is to investigate the hypothesis that delivery at 35 0/7- 35 6/7 weeks in stable patients with gastroschisis is superior to observation and expectant management with a goal of delivery at 38 0/7 - 38 6/7 weeks. To test this hypothesis, we will complete a randomized, prospective, multi-institutional trial across NAFTNet-affiliated institutions. Patients may be enrolled in the study any time prior to 33 weeks, but will be randomized at 33 weeks to delivery at 35 weeks or observation with a goal of 38 weeks. The primary composite outcome will include stillbirth, neonatal death prior to discharge, respiratory morbidity, and need for parenteral nutrition at 30 days.
⁃ To be eligible for study inclusion, subjects are required to meet the following criteria:
• Speak English or Spanish
• Age of ≥18 years old
• Have a diagnosis of an isolated fetal gastroschisis confirmed via sonogram at ≤33 weeks gestation
• Have a singleton pregnancy
• Capable of providing written informed consent for study participation
• Established Estimated Date of Confinement (EDC) prior to 22 0/7 weeks GA by last menstrual period (LMP) with ultrasound confirmation or ultrasound dating when LMP is unknown.