Fetoscopic Repair for Spina Bifida

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen ByJena B Miller, MD

Age: 18 - 65

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Johns Hopkins University

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this investigation is to evaluate maternal and fetal outcomes following fetoscopic repair of fetal spina bifida at the Johns Hopkins Hospital. The hypothesis of this study is that fetoscopic spina bifida repair is feasible and has the same effectiveness as open repair of fetal spina bifida, but with the benefit of significantly lower maternal and fetal complication rates. The fetal benefit of the procedure will be the prenatal repair of spina bifida. The maternal benefit of fetoscopic spina bifida repair will be the avoidance of a large uterine incision. This type of incision increases the risk of uterine rupture and requires that all future deliveries are by cesarean section. The use of the minimally invasive fetoscopic surgical technique may also lower the risk of preterm premature rupture of membranes and preterm birth compared to open fetal surgery. Finally, successful fetoscopic spina bifida repair also makes vaginal delivery possible.

Eligibility Criteria

This trial is for pregnant women aged 18 or older with a single baby diagnosed with isolated fetal spina bifida, where the defect is between T1-S1 vertebrae. The pregnancy should be between 19 to almost 26 weeks along, and the fetus must have a normal karyotype. Women under 18, carrying multiples, having additional fetal anomalies, facing technical issues for surgery, placenta previa or certain maternal health risks are excluded.

Inclusion Criteria

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

My unborn baby has spina bifida with the defect between the upper back and lower back.

Exclusion Criteria

I am pregnant and under 18.

Participant Groups

The study at Johns Hopkins Hospital is testing fetoscopic repair of fetal spina bifida—a minimally invasive surgery expected to be as effective as open repair but with fewer complications. Benefits may include lower risk of uterine rupture in future pregnancies and possibly allowing vaginal birth.

1Treatment groups

Experimental Treatment

Group I: FetoscopyExperimental Treatment1 Intervention

All participants will undergo fetoscopic repair of fetal spina bifida.