Fetoscopic Repair Techniques for Spina Bifida

Palo Alto (17 mi)

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

My family and I decided against ending the pregnancy before 24 weeks.

I am a pregnant woman, 18 or older, and can consent for myself.

My spinal condition is between the T1 and S1 vertebrae.

My genetic tests show no chromosomal abnormalities.

Exclusion Criteria

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

I cannot have surgery due to a past uterine procedure or condition.

I do not have a spouse, partner, or mother to support me during pregnancy.

I have a severe curvature in my upper back.

My BMI was 40 or more before I got pregnant.

I cannot have fetoscopic surgery due to conditions like fibroids or uterine issues.

Treatment Details

The 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.

1Treatment groups

Experimental Treatment

Group I: fetoscopic surgical repairExperimental Treatment1 Intervention

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