Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial

Inclusion criteria

• 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 27 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.

Exclusion criteria

• Significant fetal anomaly unrelated to gastroschisis
• Evidence of bowel perforation (presence of intraabdominal bowel calcification on ultrasonography)
• Increased risk for preterm labor including short cervical length (≤ 2.0 cm), history of incompetent cervix with or without cerclage, and previous preterm birth in a singleton pregnancy (other than a patient delivered for a non-repeating medical or surgical indication)
• Placental abnormalities (previa, abruption, accreta) known at time of enrollment
• Pre-pregnancy body-mass index (BMI) ≥40
• Contraindications to surgery including previous hysterotomy (whether from a previous classical cesarean, uterine anomaly such as an arcuate or bicornuate uterus, major myomectomy resection, or previous fetal surgery) in active uterine segment
• Technical limitations precluding fetoscopic surgery, such as extensive uterine fibroids, fetal membrane separation, or uterine anomalies
• Maternal-fetal Rh alloimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia affecting the current pregnancy.
• Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment
• Maternal medical condition that is a contraindication to surgery or general anesthesia
• Low amniotic fluid volume (Amniotic Fluid Index less than 6 cm) if deemed to be due to fetal anomaly, poor placental perfusion or function, or membrane rupture. Low amniotic fluid volume that responds to maternal hydration is not an exclusion criterion
• Patient does not have a support person (i.e., spouse, partner, or mother) available to support her for the duration of the pregnancy
• Inability to comply with the travel and follow-up requirements of the trial
• Patient scores as severely depressed on the Edinburgh Postnatal Depression Scale (EPDS)
• Patients that are enrolled or have been enrolled in any another intervention study that affects the mother or fetus
• Maternal hypersensitivity to any of the entities associated w/ AlloDerm™. The use of AlloDerm™ Regenerative Tissue Matrix distributed by Allergan Aesthetics is contraindicated for patients sensitive to any of the antibiotics listed on the AlloDerm package, i.e., Gentamycin, Cefoxitin, Lincomycin, Polymyxin B and Vancomycin or Polysorbate 20