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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Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Sundeep Keswani, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine and Texas Children's Hospital
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Successful Repair of Complex GastroschisisAt end of surgical repair
Success of primary skin closure after complete bowel reduction.