Gastroschisis Outcomes of Delivery (GOOD) Study

Recruiting now · Not applicable

Conditions studied: Gastroschisis

In brief

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.

Key facts

Study ID

NCT02774746

Run by

Medical College of Wisconsin

People needed

300

Starts

2018-02-23

Expected to finish

2029-03-31

Last updated by the study team

2026-05-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• To be eligible for study inclusion, subjects are required to meet the following criteria:
• 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
• Capable of providing written informed consent for study participation
• 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
• 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
• Maternal cervical length < 25 mm prior to 24 weeks of gestation if documented
• Maternal hypertension
• Maternal insulin-dependent diabetes
• Prenatal care initiated after 24 weeks of gestation
• 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
• Unstable pregnancy defined as meeting any of the following criteria
• 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
• Umbilical artery Dopplers with S/D ratio or resistive index (RI) > 97th percentile for age with or without absent or reversed end diastolic flow
• Non-stress test (NST) or biophysical profile (BPP) deemed non-reassuring by treating clinician
• 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
• Traditional surrogacy, gestational surrogacy, gestational carrier, or gestational surrogate
• Incapable of providing informed consent
• Are not their own legally authorized representative.

Where it is running

• Medical College of Wisconsin & Children's Wisconsin — Milwaukee, Wisconsin, United States (enrolling)
• Loma Linda University Children's Hospital — Loma Linda, California, United States (enrolling)
• Lucile Packard Children's Hospital Stanford — Stanford, California, United States (enrolling)
• Children's Hospital of Colorado — Aurora, Colorado, United States (enrolling)
• Connecticut Children's Medical Center — Hartford, Connecticut, United States (enrolling)
• Nemours Children's Hospital, Delaware — Wilmington, Delaware, United States (enrolling)
• University of South Florida & Tampa General Hospital — Tampa, Florida, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (enrolling)
• OSF St. Francis Medical Center — Peoria, Illinois, United States (enrolling)
• Riley Children's Hospital — Indianapolis, Indiana, United States (enrolling)
• Norton Healthcare, Inc. — Lousiville, Kentucky, United States (enrolling)
• University of Maryland, Baltimore — Baltimore, Maryland, United States (enrolling)
• Johns Hopkins Hospital — Baltimore, Maryland, United States (enrolling)
• Brigham and Women's Hospital & Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• CS Mott Children's & Von Voigtlander Women's Hospital, Michigan Medicine — Ann Arbor, Michigan, United States (enrolling)
• Children's MN, Midwest Fetal Care Center — Minneapolis, Minnesota, United States (enrolling)
• Children's Mercy Hospital — Kansas City, Missouri, United States (enrolling)
• St. Louis University, SSM Health Cardinal Glennon Children's Hospital & SSM Health St. Mary's Hospital — St Louis, Missouri, United States (enrolling)
• Washington University in St. Louis & St. Louis Children's Hospital — St Louis, Missouri, United States (enrolling)
• Columbia University Irving Medical Center — New York, New York, United States (enrolling)
• New York Presbyterian - Weill Cornell Medicine — New York, New York, United States (enrolling)
• University of Rochester Medical Center — Rochester, New York, United States (enrolling)
• University of North Carolina Hospitals — Chapel Hill, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.