Gastroschisis Outcomes of Delivery (GOOD) Study

February 20, 2024 updated by: Amy Wagner, Medical College of Wisconsin
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Gastroschisis is the most common congenital abdominal wall abnormality in which the intestines are outside of body floating in the amniotic fluid. This is diagnosed by prenatal ultrasound at 18-20 weeks gestation. Gastroschisis occurs in 1 out of every 4000 births and the incidence is increasing. The majority of patients with gastroschisis have an uncomplicated neonatal course and recover well after surgical repair. However, subsets of gastroschisis patients have more complicated courses due to loss of intestine or blockages of the intestine These infants have a higher risk of death and long-term morbidity. Additionally, gastroschisis patients have an increased risk of in-utero fetal demise or stillbirth.

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.

Study Type

Interventional

Enrollment (Estimated)

800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
    • California
      • Loma Linda, California, United States, 92354
        • Recruiting
        • Loma Linda University Children'S Hospital
        • Contact:
        • Contact:
          • Nikia M Gray-Hutto, RN
          • Phone Number: 15841 909-558-8000
          • Email: nhutto@llu.edu
      • Stanford, California, United States, 94305
        • Recruiting
        • Lucile Packard Children's Hospital Stanford
        • Contact:
        • Contact:
    • Colorado
    • Florida
      • Tampa, Florida, United States, 33606
        • Recruiting
        • University of South Florida & Tampa General Hospital
        • Contact:
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • Illinois
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Riley Children's Hospital
        • Contact:
        • Contact:
          • Rachell Tullar, BS
          • Phone Number: 317-274-4710
    • Kentucky
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Hospital
        • Contact:
        • Contact:
      • Baltimore, Maryland, United States, 21201
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital & Boston Children's Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Terry L Buchmiller, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • CS Mott Children's & Von Voigtlander Women's Hospital, Michigan Medicine
        • Contact:
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Active, not recruiting
        • Children's Mercy Hospital
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University in St. Louis & St. Louis Children's Hospital
        • Contact:
        • Contact:
      • Saint Louis, Missouri, United States, 63104
    • New York
      • New York, New York, United States, 10032
      • New York, New York, United States, 10065
        • Recruiting
        • New York Presbyterian - Weill Cornell Medicine
        • Contact:
      • Rochester, New York, United States, 14642
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
        • Contact:
          • Susan Grendzynski, R.N.
          • Phone Number: 216-636-6196
          • Email: sugren@ccf.org
    • Oregon
      • Portland, Oregon, United States, 97239
        • Not yet recruiting
        • Oregon Health and Science University
        • Contact:
        • Contact:
          • Raphael Sun, MD
          • Phone Number: 503-494-7776
          • Email: sunr@ohsu.edu
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
    • Tennessee
      • Nashville, Tennessee, United States, 37232
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas Health Science Center at Houston
        • Contact:
        • Contact:
      • Houston, Texas, United States, 77054
      • San Antonio, Texas, United States, 78207
    • Utah
      • Salt Lake City, Utah, United States, 84123
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Not yet recruiting
        • University of Virginia
        • Contact:
        • Contact:
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin & Children's Wisconsin
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 35-week delivery group
Subjects to be delivered at 35 0/7 weeks through 35 6/7 weeks.
Other: 35-week delivery
Induction at 35 weeks gestational age
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.
Other: 38-week delivery
Observation to spontaneous delivery or induction at 38 weeks gestational age

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the proportion of the primary weighted composite outcome (occurrence of any of the 5 clinical risks: IUFD, neonatal death, respiratory morbidity, GI morbidity, and sepsis) between groups as estimated from the ITT population.
Time Frame: NICU Discharge

The primary outcome is the weighted composite endpoint combining the following five clinical risks: intrauterine fetal demise, neonatal death prior to NICU discharge, sepsis, respiratory morbidity, and gastrointestinal morbidity. Mortality (intrauterine or neonatal death) will be considered an exclusive event.

The composite endpoint score for each subject will be computed as the sum of the weights corresponding to the events observed in the subject. The mean composite score will be compared between groups as defined by the ITT population using a two-sided test at a 4.58% nominal significance level. The nominal significance level will be adjusted based on the timing of the interim analysis if different from the original plan. This test is asymptotically equivalent to a t-test performed on the composite endpoint score. We will report the estimated difference in the weighted endpoint score along with the estimated confidence interval using the nominal significance level.
NICU Discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Investigators

  • Principal Investigator: Amy Wagner, MD, Medical College of Wisconsin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2018

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

May 11, 2016

First Submitted That Met QC Criteria

May 12, 2016

First Posted (Estimated)

May 17, 2016

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 898740-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Plan to share data if NIH funded.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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