Recruiting

Observational Study

Sponsor:

Medical College of Wisconsin

Code:

NCT02774746

Conditions

Gastroschisis

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

35-week delivery

38-week delivery

Study Details

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.

Conditions

Gastroschisis

Study ID

NCT02774746

Start date

Feb 23, 2018

Status verified date

Apr, 2026

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Mar 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 35-week delivery group

Subjects to be delivered at 35 0/7 weeks through 35 6/7 weeks.

active comparator: 38-week delivery group

Subjects to be expectantly managed to spontaneous delivery, delivered by 38 0/7 weeks through 38 6/7 weeks.

Interventions

35-week delivery

Induction at 35 weeks gestational age

38-week delivery

Observation to spontaneous delivery or induction at 38 weeks gestational age

Primary outcome measure

  • 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. [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Locations

Loma Linda University Children's Hospital

Recruiting

Loma Linda, California, United States, 92354

Contacts

Ciprian P Georghe, MD

909-558-8000CGheorghe@llu.edu

Nikia M Gray-Hutto, RN

909-558-8000nhutto@llu.edu

Lucile Packard Children's Hospital Stanford

Recruiting

Stanford, California, United States, 94305

Contacts

Children's Hospital of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Connecticut Children's Medical Center

Recruiting

Hartford, Connecticut, United States, 06106

Contacts

Nemours Children's Hospital, Delaware

Recruiting

Wilmington, Delaware, United States, 19803

Contacts

University of South Florida & Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

Contacts

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

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

Recruiting

Chicago, Illinois, United States, 60611

Contacts

OSF St. Francis Medical Center

Recruiting

Peoria, Illinois, United States, 61637

Contacts

Anthony Dwyer, PhD, MS, AHFP

adwyer1@uic.edu

Riley Children's Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Norton Healthcare, Inc.

Recruiting

Lousiville, Kentucky, United States, 40207

Contacts

University of Maryland, Baltimore

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

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

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Louise E Wilkins-Haug, MD, PhD

617-732-5452lwilkinshaug@bwh.harvard.edu

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

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

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Children's MN, Midwest Fetal Care Center

Recruiting

Minneapolis, Minnesota, United States, 55404

Contacts

Children's Mercy Hospital

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Kathleen Adderley

kadderley@cmh.edu

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

Recruiting

St Louis, Missouri, United States, 63104

Contacts

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

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

New York Presbyterian - Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Contacts

University of North Carolina Hospitals

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Amanda Kalan, M.D.

440-312-7177kalana@ccf.org

Susan Grendzynski, R.N.

216-636-6196sugren@ccf.org

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

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

Recruiting

Providence, Rhode Island, United States, 02905

Contacts

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Cook Children's Medical Center

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

University of Texas Medical Branch Galveston

Recruiting

Galveston, Texas, United States, 77555

Contacts

Ravi Radhakrishnan, MD, MBA

409-772-5666rsradhak@utmb.edu

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Christus Children's / Baylor College of Medicine

Recruiting

San Antonio, Texas, United States, 78207

Contacts

University of Utah & Primary Children's Hospital

Recruiting

Salt Lake City, Utah, United States, 84123

Contacts

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

University of Wisconsin - Madison

Recruiting

Madison, Wisconsin, United States, 53715

Contacts

Michael Beninati, MD

608-417-6009beninati@wisc.edu

Medical College of Wisconsin & Children's Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

More Information

Sponsor

Medical College of Wisconsin

Last update posted

May 27, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-07. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-05-27.