Safety and Feasibility Study of Fetoscopic Repair for Complex Gastroschisis in Pregnant Women

What this Trial Is About

Researchers are evaluating the safety and feasibility of repairing complex gastroschisis before birth using a minimally invasive fetoscopic surgical approach. Complex gastroschisis is a serious birth defect where the intestines develop outside the babys abdomen and may have complications like twisting or damage. The study aims to see if this early fetal repair can reduce risks and improve outcomes for both mother and baby. The treatment involves injecting botulinum toxin Botox into the fetus to relax abdominal muscles 1 to 2 weeks before surgery. The surgery is performed through a laparotomy where the uterus is opened, exteriorized, and the fetal defect repaired fetoscopically. After closing the uterus, the pregnancy continues. This is a single-arm study where all participants receive the fetoscopic repair. Participants will have close monitoring with ultrasounds and consultations after surgery. Delivery is planned at Texas Childrens Hospital, with infants followed for 12 months to assess survival, feeding milestones, hospital stay, growth, and development. Researchers will track multiple outcomes including surgical success, fetal and infant health complications, and long-term neurodevelopment.

Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial