Gastroschisis is the most common congenital abdominal wall abnormality in which theutside of body floating in the amniotic fluid. This is diagnosed by prenatal ultrasound at 18-20 weeks gestation. Gastroschisis occurs in 1 out of every 4000 births andhe incidence is increasing. The majority of patients with gastroschisis have an uncomplicated neonatal course and recover well after surgical repair. However, subsets of gastroschisis patients have more complicated courses due to loss of intestine or blockages ofhe intestine These infants have a higher risk of death and long-term morbidity. Additionally, gastroschisis patients have an increased risk of in-utero fetal demise orbirth.

The potential risk of pregnancy loss late in the third trimester has prompted some physiciansdeliver gastroschisis patients prior to term. This results in an increased chance ofdditional prematurity-related complications. There is no consensus about the ideal time to deliver a baby with gastroschisis and practice patterns vary widely. It is unclear whichhe fetus a chance at a better outcome: early delivery to mitigate risk of stillbirthd intestinal injury versus delivery closer to term.

Retrospective data published show inconsistent results on outcomes with early delivery orgestational age delivery in gastroschisis. There have been two randomized, prospectivewith delivery early versus awaiting spontaneous labor. The first included 42 patientsdering the study largely underpowered. There was a trend towards decreased length of hospital stay and earlier time to full enteral feeding in the early delivery group, but this did not reach statistical significance. The latest study was stopped early because ofutility and an increased risk of sepsis in the early group. There was no increase in sepsishe early group in the first trial, and the study design of this trial varies greatly from both studies.

Standard delivery times for uncomplicated gastroschisis are between 34 and 39 weeks gestation. As the current available literature does not adequately answer the question ofgestational age of delivery in patients with gastroschisis, the objective of thisudy is to investigate the hypothesis that delivery at 35 0/7 - 35 6/7 weeks in stablewith gastroschisis is superior to observation and expectant management with a goaldelivery at 38 0/7 - 38 6/7 weeks. To test this hypothesis, we will complete a randomized,ve, multi-institutional trial. Patients may be enrolled in the study any time prior33 weeks but will be randomized at 33 weeks to delivery at 35 weeks or observation with a goal of 38 weeks. The primary outcome will be based on a weighted composite comprised ofuterine fetal demise, neonatal/infant death prior to discharge, respiratory morbidity, gastrointestinal morbidity, and sepsis. We will compare the rates of the composite outcome as well as the individual components to determine whether a significant difference between thewo strategies can be detected. Secondary maternal outcomes include need for labor induction,d for cesarean section, and complications of delivery including infection, bloodusions, and thromboembolic events. We will also evaluate antenatal test values, such asuid index, estimated fetal weight, and intra- and extra-abdominal bowel dilation.dary neonatal outcomes include birth and discharge weight, central venous catheter days,zing enterocolitis, time to enteral autonomy, individualy morbidity, need for caffeine, and length of stay.

Given the unprecedented patient data being collected for the randomized trial, we plan toverage the infrastructure built for this study to generate the largest prospective,ulticenter database of gastroschisis-related (maternal, fetal, and neonatal) outcomes in thed States. The database will provide data for future development of both hypotheses andudy design regarding gastroschisis-related outcomes. The associated biobank will collect blood from the neonatal participants to be stored and analyzed in future research.