Actively Recruiting
Gastroschisis Outcomes of Delivery (GOOD) Study comparing delivery at 35 versus 38 weeks in stable gastroschisis pregnancies
Led by Medical College of Wisconsin · Updated on 2026-05-27
300
Participants Needed
38
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Gastroschisis is a common birth defect where the intestines develop outside the baby's body. This trial evaluates whether delivering babies with stable gastroschisis at 35 weeks is better than waiting for delivery at 38 weeks. The study aims to find out which timing reduces risks like stillbirth, early death, breathing problems, and need for special nutrition. It is a multi-center, randomized trial across several institutions affiliated with NAFTNet. Participants are randomly assigned at 33 weeks to either have delivery induced between 35 0/7 and 35 6/7 weeks or to be observed and delivered between 38 0/7 and 38 6/7 weeks. The study compares these two strategies to see which leads to better outcomes for the baby. Secondary outcomes include delivery complications, maternal health issues, and detailed prenatal test results, along with various newborn health measures such as birth weight and infection rates. During the trial, participants will be closely monitored from consent until the infant's discharge from the neonatal intensive care unit, which may last up to 30 weeks depending on recovery. Researchers will collect data on fetal health, delivery details, and newborn progress. Blood samples from newborns will be stored for future research. The trial will build a large database to support further study of gastroschisis outcomes in the United States.
CONDITIONS
Brief Title
Gastroschisis Outcomes of Delivery (GOOD) Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Speak English or Spanish
- Age 18 years or older
- Diagnosed with isolated fetal gastroschisis confirmed by sonogram at or before 33 weeks gestation
- Singleton pregnancy
- Able to provide written informed consent
- Established estimated due date before 22 weeks gestation by last menstrual period with ultrasound confirmation or ultrasound dating if LMP unknown
You will not qualify if you...
- Fetal anomalies unrelated to gastroschisis, such as chromosomal abnormalities or other congenital defects
- Severe fetal growth restriction below the 5th percentile for gestational age
- Maternal history of previous stillbirth
- Maternal history of spontaneous preterm delivery before 36 weeks
- Maternal cervical length less than 25 mm before 24 weeks gestation if documented
- Maternal hypertension
- Maternal insulin-dependent diabetes
- Prenatal care started after 24 weeks gestation
- Active COVID-19 infection not recovered by randomization date
- Unstable pregnancy defined by abnormal amniotic fluid volume, abnormal umbilical artery Dopplers, or non-reassuring fetal testing
- Enrollment in another study affecting delivery plan or outcomes
- Use of traditional or gestational surrogacy
- Unable to provide informed consent or not legally authorized representative
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 33 weeks of pregnancy
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - From 33 weeks gestation until delivery at 35 or 38 weeks
Participants are randomized at 33 weeks gestation to either early delivery at 35 weeks or expectant management with delivery planned at 38 weeks. Delivery and neonatal care are provided according to group assignment.
Visits as needed for delivery and prenatal monitoring
Duration - From delivery until NICU discharge (up to approximately 30 weeks)
Participants and infants are monitored until NICU discharge to assess outcomes including survival, respiratory and gastrointestinal health, and infection.
Ongoing hospital visits until discharge
Trial Site Locations
Total: 38 locations
1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Withdrawn
2
Loma Linda University Children's Hospital
Loma Linda, California, United States, 92354
Actively Recruiting
3
Lucile Packard Children's Hospital Stanford
Stanford, California, United States, 94305
Actively Recruiting
4
Children's Hospital of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Actively Recruiting
6
Nemours Children's Hospital, Delaware
Wilmington, Delaware, United States, 19803
Actively Recruiting
7
University of South Florida & Tampa General Hospital
Tampa, Florida, United States, 33606
Actively Recruiting
8
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
9
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
10
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
Actively Recruiting
11
Riley Children's Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
12
Norton Healthcare, Inc.
Lousiville, Kentucky, United States, 40207
Actively Recruiting
13
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201
Actively Recruiting
14
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
15
Brigham and Women's Hospital & Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
16
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
17
CS Mott Children's & Von Voigtlander Women's Hospital, Michigan Medicine
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
18
Children's MN, Midwest Fetal Care Center
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
19
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Actively Recruiting
20
St. Louis University, SSM Health Cardinal Glennon Children's Hospital & SSM Health St. Mary's Hospital
St Louis, Missouri, United States, 63104
Actively Recruiting
21
Washington University in St. Louis & St. Louis Children's Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
22
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
23
New York Presbyterian - Weill Cornell Medicine
New York, New York, United States, 10065
Actively Recruiting
24
University of Rochester Medical Center
Rochester, New York, United States, 14642
Actively Recruiting
25
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
26
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
27
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
28
Women & Infants Hospital/Rhode Island Hospital (Hasbro Children's)
Providence, Rhode Island, United States, 02905
Actively Recruiting
29
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
30
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Actively Recruiting
31
University of Texas Medical Branch Galveston
Galveston, Texas, United States, 77555
Actively Recruiting
32
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
33
The Woman's Hospital of Texas / Obstetrix Maternal-Fetal Medicine Specialists of Houston
Houston, Texas, United States, 77054
Withdrawn
34
Christus Children's / Baylor College of Medicine
San Antonio, Texas, United States, 78207
Actively Recruiting
35
University of Utah & Primary Children's Hospital
Salt Lake City, Utah, United States, 84123
Actively Recruiting
36
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
37
University of Wisconsin - Madison
Madison, Wisconsin, United States, 53715
Actively Recruiting
38
Medical College of Wisconsin & Children's Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
R
Rachel Bailey, BS
S
Sam Oswald, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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