RecruitingNot ApplicableNCT02774746

Gastroschisis Outcomes of Delivery (GOOD) Study


Sponsor

Medical College of Wisconsin

Enrollment

300 participants

Start Date

Feb 23, 2018

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying 35-week delivery and 38-week delivery for people with gastroschisis. The study is currently recruiting participants at 38 locations. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHER35-week delivery

Induction at 35 weeks gestational age

OTHER38-week delivery

Observation to spontaneous delivery or induction at 38 weeks gestational age


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

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NCT02774746


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