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Timing is everything: study tests best delivery week for gastroschisis babies

NCT ID NCT02774746

Disease control Sponsor: Medical College of Wisconsin Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether delivering babies with gastroschisis at 35 weeks is better than waiting until 38 weeks. Gastroschisis is a birth defect where the baby's intestines stick out of a hole in the belly. The study will track 300 pregnant people and compare risks like stillbirth, newborn death, infection, and breathing problems. The goal is to find the safest delivery timing for these babies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2018

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

gastroschisis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastroschisis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    36 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

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

    RECRUITING

    Boston, Massachusetts, 02115, United States

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

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Children's Hospital of Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's MN, Midwest Fetal Care Center

    RECRUITING

    Minneapolis, Minnesota, 55404, United States

  • Children's Mercy Hospital

    RECRUITING

    Kansas City, Missouri, 64108, United States

  • Christus Children's / Baylor College of Medicine

    RECRUITING

    San Antonio, Texas, 78207, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Columbia University Irving Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Connecticut Children's Medical Center

    RECRUITING

    Hartford, Connecticut, 06106, United States

  • Cook Children's Medical Center

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Johns Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Loma Linda University Children's Hospital

    RECRUITING

    Loma Linda, California, 92354, United States

  • Lucile Packard Children's Hospital Stanford

    RECRUITING

    Stanford, California, 94305, United States

  • Medical College of Wisconsin & Children's Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Nemours Children's Hospital, Delaware

    RECRUITING

    Wilmington, Delaware, 19803, United States

  • New York Presbyterian - Weill Cornell Medicine

    RECRUITING

    New York, New York, 10065, United States

  • Norton Healthcare, Inc.

    RECRUITING

    Lousiville, Kentucky, 40207, United States

  • OSF St. Francis Medical Center

    RECRUITING

    Peoria, Illinois, 61637, United States

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Phoenix Children's Hospital

    WITHDRAWN

    Phoenix, Arizona, 85016, United States

  • Riley Children's Hospital

    RECRUITING

    Indianapolis, Indiana, 46202, United States

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

    RECRUITING

    St Louis, Missouri, 63104, United States

  • The University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77030, United States

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

    WITHDRAWN

    Houston, Texas, 77054, United States

  • University of Maryland, Baltimore

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of North Carolina Hospitals

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of Rochester Medical Center

    RECRUITING

    Rochester, New York, 14642, United States

  • University of South Florida & Tampa General Hospital

    RECRUITING

    Tampa, Florida, 33606, United States

  • University of Texas Medical Branch Galveston

    RECRUITING

    Galveston, Texas, 77555, United States

  • University of Utah & Primary Children's Hospital

    RECRUITING

    Salt Lake City, Utah, 84123, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • University of Wisconsin - Madison

    RECRUITING

    Madison, Wisconsin, 53715, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

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

    RECRUITING

    St Louis, Missouri, 63110, United States

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

    RECRUITING

    Providence, Rhode Island, 02905, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.