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

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 3

Inclusion Criteria

Not provided

Exclusion Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pregnant women diagnosed with fetal myelomeningocele	Minimally invasive fetoscopic repair of MMC	Women subjects who are pregnant and diagnosed with myelomeningocele (MMC), also known as fetal spina bifida or neural tube defect, will undergo a minimally invasive fetoscopic repair of MMC.

Primary Outcome Measures

Name	Time	Method
Maternal Adverse Events	From time of surgery until delivery (up to 21 weeks)	Total number of maternal adverse events
Neonatal Adverse Events	From the time of surgery until 28 days of life (up 25 weeks)	Total number of neonatal adverse events

Secondary Outcome Measures