Cryopreserved Human Umbilical Cord as a Meningeal Patch in Fetoscopic Spina Bifida Repair (NCT06042140) | Clinical Trial Compass
RecruitingNot Applicable
Cryopreserved Human Umbilical Cord as a Meningeal Patch in Fetoscopic Spina Bifida Repair
United States100 participantsStarted 2023-09-08
Plain-language summary
The objective is to test the efficacy of a laparotomy-assisted fetoscopic surgical approach to cover spina bifida spinal cord developmental defects using cryopreserved human umbilical cords (NEOX Cord 1K®) as a meningeal and skin patch.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Singleton pregnancy
✓. Gestational age at screening is 19 to 25 5/7 weeks and gestational age at surgery is 22 to 25 6/7 weeks
✓. Maternal age: 18 years and older
✓. Body mass index ≤45 kg/m2 (pre-pregnancy)
✓. No preterm birth risk factors (short cervix \<20 mm or a history of previous preterm delivery)
✓. No previous uterine incision in the active uterine segment
✓. Willing to undergo an open fetal repair if the fetoscopic approach is unsuccessful
✓. Spina bifida defect between T1 to S1 vertebral levels