Gastroschisis Outcomes of Delivery (GOOD) Study

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Trial ID: NCT02774746

Purpose

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.

Official Title

Gastroschisis Outcomes of Delivery (GOOD) Study

Stanford Investigator(s)

Eligibility

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 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
8. Prenatal care initiated after 24 weeks of gestation
9. An active case of COVID-19 (confirmed by a positive test for COVID-19) that is not recovered (confirmed by a negative test for COVID-19) by the date of randomization
10. Unstable pregnancy defined as meeting any of the following criteria

1. Abnormal amniotic fluid volume defined as oligohydramnios or polyhydramnios where the maximal vertical pocket (MVP) is \< 2 cm or \> 8 cm in the third trimester, respectively
2. Umbilical artery Dopplers with S/D ratio or resistive index (RI) \> 97th percentile for age with or without absent or reversed end diastolic flow
3. Non-stress test (NST) or biophysical profile (BPP) deemed non-reassuring by treating clinician
11. Concurrent enrollment in another study that requires either a treatment or intervention which would either alter the delivery plan or potentially influence the maternal, fetal, and neonatal outcomes of this study
12. Traditional surrogacy, gestational surrogacy, gestational carrier, or gestational surrogate
13. Incapable of providing informed consent
14. Are not their own legally authorized representative.

Intervention(s):

other: 35-week delivery

other: 38-week delivery

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Yair J Blumenfeld, MD
650-724-2221