Investigating the best delivery timing for babies with gastroschisis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to determine whether delivering babies diagnosed with gastroschisis at 35 weeks of gestation is more beneficial than waiting until 38 weeks. It involves a randomized, prospective approach across multiple institutions, enrolling patients before 33 weeks and randomizing them to either early delivery or observation. The primary outcomes measured will include stillbirth, neonatal death, respiratory issues, and the need for parenteral nutrition within the first 30 days after birth. The goal is to find the optimal timing for delivery to improve neonatal outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Loma Linda University Children's Hospital
  Loma Linda, California, United States Recruiting
• Lucile Packard Children's Hospital Stanford
  Stanford, California, United States Recruiting
• Children's Hospital of Colorado
  Aurora, Colorado, United States Recruiting
• Connecticut Children's Medical Center
  Hartford, Connecticut, United States Recruiting
• Nemours Children's Hospital, Delaware
  Wilmington, Delaware, United States Recruiting
• University of South Florida & Tampa General Hospital
  Tampa, Florida, United States Recruiting

Study contacts

• Principal investigator: Amy Wagner, MD — Medical College of Wisconsin
• Study coordinator: Rachel Bailey, BS
• Email: rbailey@childrenswi.org
• Phone: 414-337-7348

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Fetal repair of complex gastroschisis using a fetoscopic approach

  This trial will try a minimally invasive fetoscopic surgery, with preoperative Botox, to repair complex gastroschisis before birth in eligible pregnant people between about 20 and 28 weeks to see if it lowers newborn complications and death.

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• Monitoring fetal heart activity in high-risk pregnancies to prevent stillbirth

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.