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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

Must not have

Fetal anomaly unrelated to gastroschisis, such as a chromosomal abnormality or another congenital structural abnormality (if known; no additional testing required for research participation)

Severe intrauterine growth restriction / fetal growth restriction (defined as growth below the 5th percentile for gestational age)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up nicu discharge

Awards & highlights

No Placebo-Only Group

Pivotal Trial

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My baby has no known birth defects unrelated to gastroschisis.

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My baby is growing slower than expected in the womb.

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I currently have COVID-19, confirmed by a positive test.

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My pregnancy is considered unstable due to one or more specific medical concerns.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ nicu discharge

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.