The purpose of this study is to evaluate the feasibility and effectiveness of performing fetoscopic surgical correction of fetal spina bifida. Two surgical approaches will be utilized: the percutaneous technique versus the laparotomy/uterine exteriorization technique.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
The percutaneous approach uses endoscopes through a closed maternal abdomen and closed uterus to perform the spina bifida correction.
The laparotomy/uterine exteriorization technique uses endoscopes through an open abdomen and closed, exteriorized uterus to perform the spina bifida correction.
Hollywood Presbyterian Medical Center
Los Angeles, California, United States
RECRUITINGWellington Regional Medical Center
Wellington, Florida, United States
RECRUITINGAbility to perform the endoscopic procedure
Successful fetoscopic closure of the defect
Time frame: At time of surgery
Chiari II malformation reversal
Reversal of hindbrain herniation on ultrasound and MRI
Time frame: Prior to delivery
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