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Early vs Standard Delivery for Gastroschisis

Phase 3
Recruiting
Led By Amy Wagner, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age of ≥18 years old
Have a diagnosis of an isolated fetal gastroschisis confirmed via sonogram at ≤33 weeks gestation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up nicu discharge
Awards & highlights

Study Summary

This trial is investigating whether delivering a baby at 35 weeks (3 and a half months) is better than waiting to deliver at 38 weeks (3 and a half months) for babies with gastroschisis, a birth defect where the intestines stick out of the stomach.

Who is the study for?
This trial is for pregnant women over 18 with a single baby diagnosed with gastroschisis via sonogram by 33 weeks. They must have started prenatal care before 24 weeks, speak English or Spanish, and be able to consent. Excluded are those with certain health issues like preterm delivery history, severe diabetes, hypertension, or unstable pregnancies.Check my eligibility
What is being tested?
The GOOD Study is comparing outcomes of delivering babies at either 35 weeks or waiting until around 38 weeks in cases of gastroschisis. It's a randomized study across multiple hospitals to see if earlier delivery reduces risks like stillbirth and respiratory problems.See study design
What are the potential side effects?
Since the interventions involve timing of delivery rather than medication, there aren't typical side effects as seen with drugs. However, early delivery may carry risks such as respiratory distress for the newborn.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My unborn baby has been diagnosed with gastroschisis before 33 weeks of pregnancy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~nicu discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and nicu discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.

Trial Design

2Treatment groups
Active Control
Group I: 35-week delivery groupActive Control1 Intervention
Subjects to be delivered at 35 0/7 weeks through 35 6/7 weeks.
Group II: 38-week delivery groupActive Control1 Intervention
Subjects to be expectantly managed to spontaneous delivery, delivered by 38 0/7 weeks through 38 6/7 weeks.

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
608 Previous Clinical Trials
1,161,697 Total Patients Enrolled
1 Trials studying Gastroschisis
200 Patients Enrolled for Gastroschisis
Amy Wagner, MDPrincipal Investigator - Medical College of Wisconsin
Children's Hospital of Wisconsin
Medical College Of Wisconsin (Medical School)

Media Library

35-week delivery Clinical Trial Eligibility Overview. Trial Name: NCT02774746 — Phase 3
Gastroschisis Research Study Groups: 35-week delivery group, 38-week delivery group
Gastroschisis Clinical Trial 2023: 35-week delivery Highlights & Side Effects. Trial Name: NCT02774746 — Phase 3
35-week delivery 2023 Treatment Timeline for Medical Study. Trial Name: NCT02774746 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers actively looking for participants in this trial right now?

"The clinical trial is currently looking for participants. 28 sites are recruiting a total of 800 patients. The study was first posted on February 23, 2018 and updated November 1, 2022 according to the data available on clinicaltrials.gov"

Answered by AI

Does the 38-week delivery group present any dangers to patients?

"There is some efficacy data and numerous rounds of safety trials, so the 38-week delivery group was given a score of 3 for safety."

Answered by AI
~264 spots leftby Mar 2027