Minimally Invasive Fetoscopic Regenerative Repair of Spina Bifida - A Pilot Study

Exclusion Criteria

• •* Fetal anomaly unrelated to MMC.
• •* Multiple gestation
• •* Declined invasive testing for karyotype (amniocentesis or CVS)
• •* Severe kyphosis (defined as curvature of the spina (vertebras) higher than 30o degree measured by ultrasonography or magnetic resonance imaging).
• •* Increased risk for preterm labor including short cervical length (\<2.0 cm), history of incompetent cervix with or without cerclage, and previous preterm birth.
• •* Placental abnormalities (previa, abruption, accreta) known at time of enrollment.
• •* A body-mass index ≥40 at first prenatal visit.
• •* 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 uterine fibroids, fetal membrane separation, uterine anomalies incompatible with fetoscopy.
• •* Amniotic Fluid Index (AFI) \< 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.
• •* Maternal-fetal Rh isoimmunization, 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 patients 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 anesthesia.
• •* A score of ≥ 29 on the Beck Depression Inventory (BDI) at screening
• •* Maternal hypersensitivity to collagen
• •* Patient does not have a support person (i.e. Spouse, partner, mother) available to support the patient for the duration of the pregnancy.
• •* Inability to comply with the travel and follow-up requirements of the trial.
• •* Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy.