Fetoscopic Repair for Spina Bifida
(fMMC Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byMichael A. Belfort, M.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?

This trial is testing a new minimally invasive surgery to fix a spinal defect in unborn babies. The surgery uses tiny tools and cameras inserted through small openings, aiming to reduce risks for both mother and baby. It targets pregnant women whose fetuses have been diagnosed with myelomeningocele (MMC), a severe form of spina bifida. This new treatment technique allows early closure of the spinal defect to prevent potential neurological and psychomotor complications.

Eligibility Criteria

This trial is for pregnant women aged 18 or older with a single pregnancy and fetal MMC located between T1 and S1, showing hindbrain herniation. The fetus must not have chromosomal abnormalities, be within 19-25 weeks gestation, and the family should reject termination of pregnancy. Women must have social support, understand study requirements, and consent to follow-up after birth.

Inclusion Criteria

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

My genetic tests show no chromosomal abnormalities.

My genetic tests from amniocentesis or CVS show normal results, or I have a balanced translocation with no other issues.

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Exclusion Criteria

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

You have a condition that could harm your baby during this pregnancy.

Inability to comply with the travel and follow-up requirements of the trial

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Treatment Details

Interventions

Fetoscopic Meningomyelocele Repair (Other)

Trial OverviewThe study tests a new fetoscopic technique to repair fetal MMC without making a uterine incision in the mother. This could reduce maternal-fetal risks compared to open surgery, potentially avoid cesarean sections for future births, decrease premature membrane rupture risk, and allow vaginal delivery if successful.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: fetoscopic surgical repairExperimental Treatment1 Intervention

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