Gastroschisis Outcomes of Delivery (GOOD) Study
Medical College of Wisconsin
Summary
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.
Description
Gastroschisis is the most common congenital abdominal wall abnormality in which the intestines are outside 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 and the 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 of the intestine These infants have a higher risk of death and long-t…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion criteria: To be eligible for study inclusion, subjects are required to meet the following criteria: 1. Speak English or Spanish 2. Age of ≥18 years old 3. Have a diagnosis of an isolated fetal gastroschisis confirmed via sonogram at ≤33 weeks gestation 4. Have a singleton pregnancy 5. Capable of providing written informed consent for study participation 6. 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. Exclusion criteria: Subjects will be excluded from e…
Interventions
- Other35-week delivery
Induction at 35 weeks gestational age
- Other38-week delivery
Observation to spontaneous delivery or induction at 38 weeks gestational age
Locations (38)
- Phoenix Children's HospitalPhoenix, Arizona
- Loma Linda University Children's HospitalLoma Linda, California
- Lucile Packard Children's Hospital StanfordStanford, California
- Children's Hospital of ColoradoAurora, Colorado
- Connecticut Children's Medical CenterHartford, Connecticut
- Nemours Children's Hospital, DelawareWilmington, Delaware