Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial
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.
• Pregnant women - maternal age 18 years or older and capable of consenting for her own participation in this study
• Singleton pregnancy
• Sonographic evidence of gastroschisis (exteriorization of bowel content outside the fetal abdominal cavity into the amniotic cavity)
• Intraabdominal bowel dilation ≥ 8 mm at 20-24 weeks GA reviewed by prenatal ultrasound
• Absence of significant associated anomalies\* diagnosed on prenatal ultrasound or MRI
• Gestational age at the time of the procedure will be between 20 0/7 weeks and 25 6/7 weeks
• 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 weeks. Patients declining invasive testing will be excluded
• The family has considered and declined the option of termination of the pregnancy at less than 24 weeks and of standard postnatal treatment
• The family meets psychosocial criteria (sufficient social support, ability to understand the requirements of the study)
⁃ Parental/guardian permission (informed consent) for follow up of the child after birth
‣ 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.