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RECRUITING NA

Gastroschisis Outcomes of Delivery (GOOD) Study

NCT02774746 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • OTHER 35-week delivery
  • OTHER 38-week delivery

Study Locations (20)

California

  • Loma Linda University Children's Hospital — Loma Linda
  • Lucile Packard Children's Hospital Stanford — Stanford

Illinois

  • Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
  • OSF St. Francis Medical Center — Peoria

Maryland

  • University of Maryland, Baltimore — Baltimore
  • Johns Hopkins Hospital — Baltimore

Massachusetts

  • Brigham and Women's Hospital & Boston Children's Hospital — Boston
  • Beth Israel Deaconess Medical Center — Boston

Missouri

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

Arizona

  • Phoenix Children's Hospital — Phoenix

Colorado

  • Children's Hospital of Colorado — Aurora

Connecticut

  • Connecticut Children's Medical Center — Hartford

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2018-02-23
Est. Completion 2029-03-31
Phase NA

Sponsor

Medical College of Wisconsin

614 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02774746

The ClinicalTrials.gov registry entry for NCT02774746 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 614 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Gastroschisis appearing as the primary indexed condition, and to 2 interventions — of which 35-week delivery is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02774746 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Illinois, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02774746 about?

NCT02774746 is a clinical study titled "Gastroschisis Outcomes of Delivery (GOOD) Study". 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, prosp...

What is the current status of trial NCT02774746?

This trial is currently recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2018-02-23. Estimated completion is 2029-03-31.

What conditions does trial NCT02774746 study?

This clinical trial studies the following conditions: Gastroschisis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02774746?

The interventions under investigation include: 35-week delivery (OTHER), 38-week delivery (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02774746?

This trial is sponsored by Medical College of Wisconsin, which has 614 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02774746 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial