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Investigating the best delivery timing for babies with gastroschisis

Gastroschisis Outcomes of Delivery (GOOD) Study

Not applicable Interventional Medical College of Wisconsin · NCT02774746

This study is testing if delivering babies with gastroschisis at 35 weeks is better for their health than waiting until 38 weeks.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment300 (estimated)
Ages18 Years and up
SexFemale
SponsorMedical College of Wisconsin Academic / other
Locations38 sites (Phoenix, Arizona and 37 other locations)
Trial IDNCT02774746 on ClinicalTrials.gov

What this trial studies

This study aims to determine whether delivering babies diagnosed with gastroschisis at 35 weeks of gestation is more beneficial than waiting until 38 weeks. It involves a randomized, prospective approach across multiple institutions, enrolling patients before 33 weeks and randomizing them to either early delivery or observation. The primary outcomes measured will include stillbirth, neonatal death, respiratory issues, and the need for parenteral nutrition within the first 30 days after birth. The goal is to find the optimal timing for delivery to improve neonatal outcomes.

Who should consider this trial

Good fit: Ideal candidates are pregnant individuals aged 18 or older with a singleton pregnancy diagnosed with isolated fetal gastroschisis before 33 weeks gestation.

Not a fit: Patients with additional fetal anomalies or severe intrauterine growth restriction may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved survival rates and reduced complications for infants born with gastroschisis.

How similar studies have performed: Previous studies on delivery timing for gastroschisis have shown inconsistent results, making this approach novel and necessary for further investigation.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Phoenix, Arizona and 37 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Gastroschisis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.