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Fetoscopic Repair Techniques for Spina Bifida

Phase 1
Waitlist Available
Led By Michael A. Belfort, M.D., Ph.D.
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The family has considered and declined the option of termination of the pregnancy at less than 24 weeks
Pregnant women - maternal age 18 years or older and capable of consenting for their own participation in this study
Must not have
Maternal medical condition that is a contraindication to surgery or anesthesia
Contraindications to surgery including previous hysterotomy (whether from a previous classical cesarean, uterine anomaly such as an arcuate or bicornuate uterus, major myomectomy resection, or previous fetal surgery) in active uterine segment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at birth
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare two techniques for repairing a birth defect called myelomeningocele. One technique uses a patch and the other does not. The hypothesis is that the technique with the patch will result in a thicker repair and less chance of the repair coming apart.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects aren't specified but may include risks associated with any surgical procedure such as infection risk at the incision site, adverse reactions to anesthesia or materials used like the Durepair patch (if allergic), and complications related to preterm labor.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My family and I decided against ending the pregnancy before 24 weeks.
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I am a pregnant woman, 18 or older, and can consent for myself.
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My spinal condition is between the T1 and S1 vertebrae.
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My genetic tests show no chromosomal abnormalities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a health condition that makes surgery or anesthesia unsafe for me.
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I cannot have surgery due to a past uterine procedure or condition.
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I do not have a spouse, partner, or mother to support me during pregnancy.
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I have a severe curvature in my upper back.
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My BMI was 40 or more before I got pregnant.
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I cannot have fetoscopic surgery due to conditions like fibroids or uterine issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at birth
This trial's timeline: 3 weeks for screening, Varies for treatment, and at birth for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
MMC Repair Dehiscence and/or CSF leak

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: fetoscopic surgical repairExperimental Treatment1 Intervention
Single arm study. All patients will receive the fetoscopic repair.

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,025 Previous Clinical Trials
6,029,744 Total Patients Enrolled
3 Trials studying Neural Tube Defects
161 Patients Enrolled for Neural Tube Defects
Michael A. Belfort, M.D., Ph.D.Principal InvestigatorBaylor College of Medicine

Media Library

Patch (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03794011 — Phase 1
Neural Tube Defects Clinical Trial 2023: Patch Highlights & Side Effects. Trial Name: NCT03794011 — Phase 1
Patch (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03794011 — Phase 1
~8 spots leftby Aug 2026
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