Gastroschisis Outcomes of Delivery (GOOD) Study
This study is looking at the best time to deliver babies with gastroschisis (a condition where the intestines are outside the body). Researchers want to see if delivering at 35 weeks is better than waiting until 38 weeks. You might be able to join if you are at least 18 years old, speak English or Spanish, and have a single pregnancy where your baby has isolated gastroschisis diagnosed by 33 weeks. The study will compare how many babies in each group experience stillbirth, neonatal death, or sepsis (a serious infection). This study is currently unclear about its status and plans to enroll 300 participants.
- Study design
- This is an interventional study that will randomly assign participants to one of two delivery timing groups. It will involve multiple institutions.
- What's involved
- You would be randomized at 33 weeks to either an induction at 35 weeks or observation with a goal of delivery at 38 weeks. The study will follow your baby from consent until NICU discharge, which can be up to 30 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed from the date of consent until NICU discharge, which can take up to 30 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Gastroschisis Outcomes of Delivery (GOOD) Study
At a glance
Conditions
Where it's being run
38 sites across 25 statesStudy leadership
- Amy Wagner, MD · PRINCIPAL_INVESTIGATOR · Medical College of Wisconsin
Who to contact
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What this trial measures
- Comparison of the proportion of the primary composite outcome (occurrence of any of the 3 clinical risks: IUFD, neonatal death, and sepsis) between groups as estimated from the ITT population.Date of consent until NICU Discharge. Discharge dates for patients vary and depend on each individual's recovery progress, medical needs, and overall condition. In general, this entire time frame can take up to 30 weeks.
The primary outcome is the composite endpoint combining the following three clinical risks: (1) intrauterine fetal demise, (2) neonatal/infant death prior to neonatal intensive care unit (NICU) discharge, (3) sepsis. The probability of the composite endpoint will be compared between groups as defined by the ITT population using a one-sided test at a 2.3% nominal significance level for the alternative hypothesis that the experimental early delivery group has lower probability of the composite endpoint compared to term delivery group. The nominal significance level will be adjusted based on the timing of the interim analysis if different from the original plan. The Wald test for two proportions will be used. We will report the estimated difference in the probabilities along with the Wald confidence interval using the nominal significance level.