Fetal Repair of Complex Gastroschisis Safety and Feasibility Trial

This study is testing a new way to repair complex gastroschisis (a birth defect where a baby's intestines are outside the body) before birth. Doctors will use a procedure called fetoscopy, which involves surgery on the baby while still in the womb. Before the surgery, the baby will receive botulinum toxin type A (Botox) injections to help relax abdominal muscles. The main goal is to see if this fetal repair is safe and possible, and if it can improve outcomes for babies with complex gastroschisis. They are looking for 10 pregnant women, aged 18 or older, who are carrying a single baby with sonographic evidence of gastroschisis and specific bowel dilation. The study will measure if the repair is successful at the end of the surgery.

Study design
This is an interventional study planning to enroll 10 participants. It is a single-arm study, meaning all participants will receive the same intervention.
What's involved
Participants will undergo botulinum toxin type A injections, followed by a fetoscopic surgery to repair the gastroschisis.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome of successful repair is measured at the end of the surgical repair.

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NCT05704257

Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial

Recruiting
NAAges 18+InterventionalDevice feasibility
Baylor College of Medicine
~10 participants
Updated 2026-04-23 on ClinicalTrials.gov
What's tested:fetoscopy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Successful Repair of Complex Gastroschisis
Measured over At end of surgical repair
Gastroschisis
1 sites across 1 states
Texas1
  • Sundeep Keswani, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine and Texas Children's Hospital

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Eligibility criteria

Inclusion

Significant associated anomalies are defined as such anomalies that would, in and of themselves, be life limiting or life threatening. A minor anomaly, such as a small VSD or ASD not deemed to be life limiting or threatening, or a cleft lip or other such anomaly, unless part of a genetic syndrome, will not disqualify the patient.
  • Successful Repair of Complex GastroschisisAt end of surgical repair

    Success of primary skin closure after complete bowel reduction.