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Gastroschisis Outcomes of Delivery (GOOD) Study

Recruiting

Who can join

Ages 18 and older · Women

Full eligibility 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.

About the 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.

What is being tested

Sponsor: Medical College of Wisconsin · Participants: 300 · Started: Feb 23, 2018

Contact the study team

Official record on ClinicalTrials.gov — NCT02774746

Locations in the U.S.

CaliforniaLoma Linda University Children's Hospital, Loma Linda
Lucile Packard Children's Hospital Stanford, Stanford
ColoradoChildren's Hospital of Colorado, Aurora
ConnecticutConnecticut Children's Medical Center, Hartford
DelawareNemours Children's Hospital, Delaware, Wilmington
FloridaUniversity of South Florida & Tampa General Hospital, Tampa
GeorgiaEmory University, Atlanta
IllinoisAnn & Robert H. Lurie Children's Hospital of Chicago, Chicago
OSF St. Francis Medical Center, Peoria
IndianaRiley Children's Hospital, Indianapolis
KentuckyNorton Healthcare, Inc., Lousiville
MarylandJohns Hopkins Hospital, Baltimore
University of Maryland, Baltimore, Baltimore
MassachusettsBeth Israel Deaconess Medical Center, Boston
Brigham and Women's Hospital & Boston Children's Hospital, Boston
MichiganCS Mott Children's & Von Voigtlander Women's Hospital, Michigan Medicine, Ann Arbor
MinnesotaChildren's MN, Midwest Fetal Care Center, Minneapolis
MissouriChildren's Mercy Hospital, Kansas City
St. Louis University, SSM Health Cardinal Glennon Children's Hospital & SSM Health St. Mary's Hospital, St Louis
Washington University in St. Louis & St. Louis Children's Hospital, St Louis
New YorkColumbia University Irving Medical Center, New York
New York Presbyterian - Weill Cornell Medicine, New York
University of Rochester Medical Center, Rochester
North CarolinaUniversity of North Carolina Hospitals, Chapel Hill
OhioCleveland Clinic, Cleveland
OregonOregon Health and Science University, Portland
Rhode IslandWomen & Infants Hospital/Rhode Island Hospital (Hasbro Children's), Providence
TennesseeVanderbilt University Medical Center, Nashville
TexasCook Children's Medical Center, Fort Worth
University of Texas Medical Branch Galveston, Galveston
The University of Texas Health Science Center at Houston, Houston
Christus Children's / Baylor College of Medicine, San Antonio
UtahUniversity of Utah & Primary Children's Hospital, Salt Lake City
VirginiaUniversity of Virginia, Charlottesville
WisconsinUniversity of Wisconsin - Madison, Madison
Medical College of Wisconsin & Children's Wisconsin, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.