Fetoscopic Repair of Isolated Fetal Spina Bifida
Running, not enrolling · Not applicable
Conditions studied: Spina Bifida, Myelomeningocele, Chiari Malformation Type 2, Neural Tube Defects, Spinal Dysraphism, Congenital Abnormality
In brief
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.
Key facts
- Study ID
- NCT03090633
- Run by
- Johns Hopkins University
- People needed
- 30
- Starts
- 2017-05-11
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2026-04-13
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Pregnant women age 18 years and older who are able to consent
- Singleton pregnancy
- Normal fetal karyotype
- Isolated fetal spina bifida with the upper lesion level between T1-S1
- Gestational age between 19+0 to 25+6 weeks gestation
You may not qualify if…
- Pregnant women less than 18 years of age
- Multiple gestation
- Fetal anomaly unrelated to spina bifida
- Maternal contraindication to fetoscopic surgery
- Severe maternal medical condition in pregnancy
- Technical limitations preluding fetoscopic surgery
- Preterm labor
- Cervical length < 25mm
- Placenta previa
- Psychosocial ineligibility precluding consent
- Maternal Beck Depression Inventory score ≥ 17
Where it is running
- Johns Hopkins Hospital — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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