Gastroschisis Outcomes of Delivery (GOOD) Study
1 other identifier
interventional
300
1 country
38
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2018
Longer than P75 for not_applicable
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2016
CompletedFirst Posted
Study publicly available on registry
May 17, 2016
CompletedStudy Start
First participant enrolled
February 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2029
May 4, 2026
April 1, 2026
11.1 years
May 11, 2016
April 28, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison of the proportion of the primary composite outcome (occurrence of any of the 3 clinical risks: IUFD, neonatal death, and sepsis) between groups as estimated from the ITT population.
The primary outcome is the composite endpoint combining the following three clinical risks: (1) intrauterine fetal demise, (2) neonatal/infant death prior to neonatal intensive care unit (NICU) discharge, (3) sepsis. The probability of the composite endpoint will be compared between groups as defined by the ITT population using a one-sided test at a 2.3% nominal significance level for the alternative hypothesis that the experimental early delivery group has lower probability of the composite endpoint compared to term delivery group. The nominal significance level will be adjusted based on the timing of the interim analysis if different from the original plan. The Wald test for two proportions will be used. We will report the estimated difference in the probabilities along with the Wald confidence interval using the nominal significance level.
Date of consent until NICU Discharge. Discharge dates for patients vary and depend on each individual's recovery progress, medical needs, and overall condition. In general, this entire time frame can take up to 30 weeks.
Study Arms (2)
35-week delivery group
ACTIVE COMPARATORSubjects to be delivered at 35 0/7 weeks through 35 6/7 weeks.
38-week delivery group
ACTIVE COMPARATORSubjects to be expectantly managed to spontaneous delivery, delivered by 38 0/7 weeks through 38 6/7 weeks.
Interventions
Observation to spontaneous delivery or induction at 38 weeks gestational age
Eligibility Criteria
You may qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Loma Linda University Children's Hospital
Loma Linda, California, 92354, United States
Lucile Packard Children's Hospital Stanford
Stanford, California, 94305, United States
Children's Hospital of Colorado
Aurora, Colorado, 80045, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
Nemours Children's Hospital, Delaware
Wilmington, Delaware, 19803, United States
University of South Florida & Tampa General Hospital
Tampa, Florida, 33606, United States
Emory University
Atlanta, Georgia, 30322, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
OSF St. Francis Medical Center
Peoria, Illinois, 61637, United States
Riley Children's Hospital
Indianapolis, Indiana, 46202, United States
Norton Healthcare, Inc.
Lousiville, Kentucky, 40207, United States
University of Maryland, Baltimore
Baltimore, Maryland, 21201, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Brigham and Women's Hospital & Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
CS Mott Children's & Von Voigtlander Women's Hospital, Michigan Medicine
Ann Arbor, Michigan, 48109, United States
Children's MN, Midwest Fetal Care Center
Minneapolis, Minnesota, 55404, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
St. Louis University, SSM Health Cardinal Glennon Children's Hospital & SSM Health St. Mary's Hospital
St Louis, Missouri, 63104, United States
Washington University in St. Louis & St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
Columbia University Irving Medical Center
New York, New York, 10032, United States
New York Presbyterian - Weill Cornell Medicine
New York, New York, 10065, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
University of North Carolina Hospitals
Chapel Hill, North Carolina, 27599, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Women & Infants Hospital/Rhode Island Hospital (Hasbro Children's)
Providence, Rhode Island, 02905, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
University of Texas Medical Branch Galveston
Galveston, Texas, 77555, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
The Woman's Hospital of Texas / Obstetrix Maternal-Fetal Medicine Specialists of Houston
Houston, Texas, 77054, United States
Christus Children's / Baylor College of Medicine
San Antonio, Texas, 78207, United States
University of Utah & Primary Children's Hospital
Salt Lake City, Utah, 84123, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
University of Wisconsin - Madison
Madison, Wisconsin, 53715, United States
Medical College of Wisconsin & Children's Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amy Wagner, MD
Medical College of Wisconsin
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Pediatric Surgery
Study Record Dates
First Submitted
May 11, 2016
First Posted
May 17, 2016
Study Start
February 23, 2018
Primary Completion (Estimated)
March 31, 2029
Study Completion (Estimated)
March 31, 2029
Last Updated
May 4, 2026
Record last verified: 2026-04