Gastroschisis Outcomes of Delivery (GOOD) Study
ConditionGastroschisis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMedical College of Wisconsin
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Fetal anomaly unrelated to gastroschisis, such as a chromosomal abnormality or another congenital structural abnormality (if known; no additional testing required for research participation)
Severe intrauterine growth restriction / fetal growth restriction (defined as growth below the 5th percentile for gestational age)
Maternal history of previous stillbirth (intrauterine fetal demise)
Maternal history of spontaneous preterm (<36 weeks) delivery
Trial design
Design model
Parallel
Treatments tested in this trial
35-week delivery
Other interventionInduction at 35 weeks gestational age
38-week delivery
Other interventionObservation to spontaneous delivery or induction at 38 weeks gestational age
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: 35-week delivery groupActive comparator 1 intervention
Group B: 38-week delivery groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
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.
Time frame
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.Sponsors and contacts
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Source ClinicalTrials.gov