NCT05704257 Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial
| NCT ID | NCT05704257 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Baylor College of Medicine |
| Condition | Gastroschisis |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2023-10-20 |
| Primary Completion | 2029-12 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The goal of this clinical trial is to evaluate the safety and feasibility of fetal repair of complex gastroschisis (GS) via a fetoscopic surgical approach by assessing maternal, fetal, neonatal, and infant outcomes in a cohort of 10 patients. The hypothesis is that in utero repair of GS will reduce postnatal mortality and morbidity in complex GS infants with minimal maternal and fetal risk.
Eligibility Criteria
Inclusion Criteria: 1. Pregnant women - maternal age 18 years or older and capable of consenting for her own participation in this study 2. Singleton pregnancy 3. Sonographic evidence of gastroschisis (exteriorization of bowel content outside the fetal abdominal cavity into the amniotic cavity) 4. Intraabdominal bowel dilation ≥ 8 mm at 20-24 weeks GA reviewed by prenatal ultrasound 5. Absence of significant associated anomalies\* diagnosed on prenatal ultrasound or MRI 6. Gestational age at the time of the procedure will be between 20 0/7 weeks and 27 6/7 weeks 7. Absence of chromosomal and clinically significant abnormalities, i.e., normal karyotype and/or normal chromosomal microarray (CMA) by invasive testing (amniocentesis or Chorionic Villus Sampling (CVS)). If there is a balanced translocation with normal CMA with no other anomalies the candidate can be included. Results by fluorescence in situ hybridization (FISH) will be accepted, if the candidate's gestation age is ≥ 22 0/7 w