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RECRUITING

NCT02774746

Gastroschisis Outcomes of Delivery (GOOD) Study

Sponsor: Medical College of Wisconsin

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2018-02-23

Completion Date

2029-03-31

Last Updated

2025-11-13

Healthy Volunteers

Conditions

Gastroschisis

Interventions

OTHER

35-week delivery

Induction at 35 weeks gestational age

OTHER

38-week delivery

Observation to spontaneous delivery or induction at 38 weeks gestational age

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.

Locations (38)

Phoenix Children's Hospital

Phoenix, Arizona, United States

Loma Linda University Children's Hospital

Loma Linda, California, United States

Lucile Packard Children's Hospital Stanford

Stanford, California, United States

Children's Hospital of Colorado

Aurora, Colorado, United States

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Nemours Children's Hospital, Delaware

Wilmington, Delaware, United States

University of South Florida & Tampa General Hospital

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

OSF St. Francis Medical Center

Peoria, Illinois, United States

Riley Children's Hospital

Indianapolis, Indiana, United States

Norton Healthcare, Inc.

Lousiville, Kentucky, United States

University of Maryland, Baltimore

Baltimore, Maryland, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Brigham and Women's Hospital & Boston Children's Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

CS Mott Children's & Von Voigtlander Women's Hospital, Michigan Medicine

Ann Arbor, Michigan, United States

Children's MN, Midwest Fetal Care Center

Minneapolis, Minnesota, United States

Children's Mercy Hospital

Kansas City, Missouri, United States

St. Louis University, SSM Health Cardinal Glennon Children's Hospital & SSM Health St. Mary's Hospital

St Louis, Missouri, United States

Washington University in St. Louis & St. Louis Children's Hospital

St Louis, Missouri, United States

Columbia University Irving Medical Center

New York, New York, United States

New York Presbyterian - Weill Cornell Medicine

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

University of North Carolina Hospitals

Chapel Hill, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

Women & Infants Hospital/Rhode Island Hospital (Hasbro Children's)

Providence, Rhode Island, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Cook Children's Medical Center

Fort Worth, Texas, United States

University of Texas Medical Branch Galveston

Galveston, Texas, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

The Woman's Hospital of Texas / Obstetrix Maternal-Fetal Medicine Specialists of Houston

Houston, Texas, United States

Christus Children's / Baylor College of Medicine

San Antonio, Texas, United States

University of Utah & Primary Children's Hospital

Salt Lake City, Utah, United States

University of Virginia

Charlottesville, Virginia, United States

University of Wisconsin - Madison

Madison, Wisconsin, United States

Medical College of Wisconsin & Children's Wisconsin

Milwaukee, Wisconsin, United States