Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2018-02-23
2029-03-31
Brief Summary
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Detailed Description
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The potential risk of pregnancy loss late in the third trimester has prompted some physicians to deliver gastroschisis patients prior to term. This results in an increased chance of additional prematurity-related complications. There is no consensus about the ideal time to deliver a baby with gastroschisis and practice patterns vary widely. It is unclear which offers the fetus a chance at a better outcome: early delivery to mitigate risk of stillbirth and intestinal injury versus delivery closer to term.
Retrospective data published show inconsistent results on outcomes with early delivery or later gestational age delivery in gastroschisis. There have been two randomized, prospective trials with delivery early versus awaiting spontaneous labor. The first included 42 patients rendering the study largely underpowered. There was a trend towards decreased length of hospital stay and earlier time to full enteral feeding in the early delivery group, but this did not reach statistical significance. The latest study was stopped early because of futility and an increased risk of sepsis in the early group. There was no increase in sepsis in the early group in the first trial, and the study design of this trial varies greatly from both studies.
Standard delivery times for uncomplicated gastroschisis are between 34 and 39 weeks gestation. As the current available literature does not adequately answer the question of optimal gestational age of delivery in patients with gastroschisis, 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. 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 outcome will be based on a weighted composite comprised of intrauterine fetal demise, neonatal/infant death prior to discharge, respiratory morbidity, gastrointestinal morbidity, and sepsis. We will compare the rates of the composite outcome as well as the individual components to determine whether a significant difference between the two strategies can be detected. Secondary maternal outcomes include need for labor induction, need for cesarean section, and complications of delivery including infection, blood transfusions, and thromboembolic events. We will also evaluate antenatal test values, such as amniotic fluid index, estimated fetal weight, and intra- and extra-abdominal bowel dilation. Secondary neonatal outcomes include birth and discharge weight, central venous catheter days, sepsis, intestinal atresia, necrotizing enterocolitis, time to enteral autonomy, individual components of respiratory morbidity, need for caffeine, and length of stay.
Given the unprecedented patient data being collected for the randomized trial, we plan to leverage the infrastructure built for this study to generate the largest prospective, multicenter database of gastroschisis-related (maternal, fetal, and neonatal) outcomes in the United States. The database will provide data for future development of both hypotheses and study design regarding gastroschisis-related outcomes. The associated biobank will collect blood from the neonatal participants to be stored and analyzed in future research.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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35-week delivery group
Subjects to be delivered at 35 0/7 weeks through 35 6/7 weeks.
35-week delivery
Induction at 35 weeks gestational age
38-week delivery group
Subjects to be expectantly managed to spontaneous delivery, delivered by 38 0/7 weeks through 38 6/7 weeks.
38-week delivery
Observation to spontaneous delivery or induction at 38 weeks gestational age
Interventions
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35-week delivery
Induction at 35 weeks gestational age
38-week delivery
Observation to spontaneous delivery or induction at 38 weeks gestational age
Eligibility Criteria
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Inclusion 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
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.
18 Years
FEMALE
No
Sponsors
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Medical College of Wisconsin
OTHER
Responsible Party
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Amy Wagner
Professor, Pediatric Surgery
Principal Investigators
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Amy Wagner, MD
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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898740-1
Identifier Type: -
Identifier Source: org_study_id
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