CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 30 target
Drug / intervention
Fetoscopydevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03090633
NCT03090633N/AActiveOn TrackUpdated 2mo ago

Study of Fetoscopic Repair of Myelomeningocele in Fetuses With Isolated Spina Bifida

Johns Hopkins University·interventional·Posted Mar 27, 2017·Updated Apr 13, 2026

In Brief

A clinical study evaluating Fetoscopy for Spina Bifida and 5 related conditions. Active but no longer recruiting, targeting 30 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/AActive
20172018201920202021202220232024202520262027
First PostedMar 27, 2017
Enrollment StartMay 11, 2017
Primary CompletionApr 1, 2027
TodayJul 2, 2026
Enrollment to primary: 9.9 yearsPosted 9.3 years agoPrimary completion in 9 months

Interventions

Fetoscopydevice

Minimally invasive in-utero surgery