RecruitingGastroschisis

Gastroschisis Outcomes of Delivery (GOOD) Study

Eligible age

18+ yrs

Accepts

Women

Locations

25 states

Healthy volunteers

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About this study

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.

Sponsor: Medical College of Wisconsin

You may qualify if…

✓ 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.

You may not qualify if…

✕ Subjects will be excluded from enrollment for any of the following criteria
✕ 1. Fetal anomaly unrelated to gastroschisis, such as a chromosomal abnormality or another congenital structural abnormality (if known; no additional testing required for research participation)
✕ 2. Severe intrauterine growth restriction / fetal growth restriction (defined as growth below the 5th percentile for gestational age)
✕ 3. Maternal history of previous stillbirth (intrauterine fetal demise)
✕ 4. Maternal history of spontaneous preterm (\<36 weeks) delivery
✕ 5. Maternal cervical length \< 25 mm prior to 24 weeks of gestation if documented
✕ 6. Maternal hypertension
✕ 7. Maternal insulin-dependent diabetes