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
Qualifiers
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
Treatments tested in this trial
- 35-week delivery
- 38-week delivery
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov