Gastroschisis Outcomes of Delivery (GOOD) Study

The most frequent abdominal (belly) wall defect affecting fetuses is a condition known as gastroschisis; occurring in about 1 in 4000 births. The baby’s intestines are found outside of its body after escaping through a hole located close to the belly button. Once born, many babies with gastroschisis do well after surgery, however some babies may experience shortening, twisting, or swelling of their intestines because of amniotic fluid exposure, or suffer from increased intestinal blockages. Unfortunately, these babies have an increased risk of death before or after birth, and may endure any of a number of long-term complications. Different physicians have differing opinions on when to deliver babies with gastroschisis. In the literature it remains unclear whether delivering the baby earlier may be better than a later delivery. Some physicians think that delivering a stable baby in the 35^th week of pregnancy will be far better for the baby’s outcome than at a later time, and this study tests this question. Patients may be enrolled in this Phase 3 multi-center randomized trial before the 33^rd week of pregnancy to deliver their baby at 35 weeks or to expectant management with a goal of 38 weeks. Following this, the baby’s medical records will be evaluated until the baby is discharged from the hospital. To learn more about this study, please contact the study’s Principal Investigator, Mary Austin, MD, at [email protected], or at 713-500-7300. Additional information can be found on the clinicaltrials.gov website at https://clinicaltrials.gov/ct2/show/record/NCT02774746.