Fetoscopic Repair Techniques for Spina Bifida

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byMichael A. Belfort, M.D., Ph.D.

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Baylor College of Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of the study is to compare the maternal, fetal and neonatal outcomes of a cohort of 60 patients in whom a multilayer closure with a Durepair patch is performed with a prior cohort of patients in whom a standardized repair without patch (n = 32) was performed using the same minimally invasive fetoscopic repair technique. The hypothesis is that there will be a thicker repair (as measured by MRI at 6 weeks post surgery) and less MMC repair dehiscence and/or CSF leak with the patch repair.

Eligibility Criteria

This trial is for pregnant women aged 18 or older with a single pregnancy, carrying a fetus with spina bifida (MMC) located between T1 and S1 vertebrae, without chromosomal abnormalities. The surgery occurs between 19-25 weeks of gestation. Candidates must have declined pregnancy termination, meet psychosocial criteria, and consent to child follow-up post-birth. Exclusions include fetal anomalies unrelated to MMC, obesity (BMI ≥40), certain placental/uterine conditions, severe depression, collagen hypersensitivity, specific infections like HIV/Hepatitis-B/C.

Inclusion Criteria

Gestational age at the time of the procedure will be between 19 0/7 weeks and 25 6/7 weeks

Parental/guardian permission (informed consent) for follow up of the child after birth

My ultrasound shows a clear area on my uterus for surgery without placental interference.

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Exclusion Criteria

The pregnant person is allergic to collagen.

Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy

I have a health condition that makes surgery or anesthesia unsafe for me.

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Treatment Details

Interventions

Patch (Other)

Trial OverviewThe study tests if using a Durepair patch in fetoscopic repair of spina bifida leads to better outcomes compared to standard no-patch repair. Outcomes are measured by MRI at 6 weeks post-surgery focusing on the thickness of the repair and incidences of dehiscence or CSF leaks.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: fetoscopic surgical repairExperimental Treatment1 Intervention

Single arm study. All patients will receive the fetoscopic repair.