Pilot Study Comparing Two Fetoscopic Surgical Methods for In Utero Correction of Myelomeningocele in Pregnant Women

What this Trial Is About

Researchers are studying a surgical technique called fetoscopy to correct fetal myelomeningocele, a form of spina bifida, before birth. This pilot study compares two surgical approaches a percutaneous method offered to patients with a posterior placenta, and a laparotomy with uterine exteriorization method available to all participants regardless of placental location. The goal is to see if these techniques can successfully close the myelomeningocele defect before delivery. Participants will receive fetoscopic repair of the myelomeningocele using one of the two surgical approaches based on their placental position and preference. Those with an anterior placenta will undergo the laparotomy method, while those with a posterior placenta may choose either the percutaneous or laparotomy approach. The study evaluates the success rate of these in-utero surgeries from the time of operation until delivery, lasting up to 21 weeks. During the study, participants will undergo MRI and ultrasound to confirm lesion and hindbrain herniation levels. Social work and pediatric neurology consultations will assess eligibility and support. Participants must remain near the medical center for pregnancy and delivery and return for follow-up visits at 12, 24, 30, 48, and 60 months after birth. The study tracks surgical outcomes and monitors safety and development over time.

Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele