Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial

Exclusion Criteria

• •1. Significant fetal anomaly unrelated to gastroschisis
• •2. Evidence of bowel perforation (presence of intraabdominal bowel calcification on ultrasonography)
• •3. 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)
• •4. Placental abnormalities (previa, abruption, accreta) known at time of enrollment
• •5. Pre-pregnancy body-mass index (BMI) ≥40
• •6. 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
• •7. Technical limitations precluding fetoscopic surgery, such as extensive uterine fibroids, fetal membrane separation, or uterine anomalies
• •8. Maternal-fetal Rh alloimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia affecting the current pregnancy.
• •9. 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
• •10. Maternal medical condition that is a contraindication to surgery or general anesthesia
• •11. 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
• •12. Patient does not have a support person (i.e., spouse, partner, or mother) available to support her for the duration of the pregnancy
• •13. Inability to comply with the travel and follow-up requirements of the trial
• •14. Patient scores as severely depressed on the Edinburgh Postnatal Depression Scale (EPDS)
• •15. Patients that are enrolled or have been enrolled in any another intervention study that affects the mother or fetus
• •16. 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