Keyhole surgery in the womb could fix spina bifida with fewer risks

NCT ID NCT03090633

Disease control Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a minimally invasive fetoscopic surgery to repair spina bifida in unborn babies. The goal is to close the spinal defect and reverse brain herniation while reducing risks like uterine rupture and preterm birth that come with open fetal surgery. Thirty pregnant women with isolated spina bifida will be enrolled to see if this approach is both feasible and safer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: fetoscopic surgery (minimally invasive in-utero procedure using specialized endoscopes and instruments)
What this could lead to: If successful, this could offer a safer way to repair spina bifida before birth, reducing complications like uterine rupture and preterm birth, and possibly allowing vaginal delivery.
What could go wrong: This is a small, early feasibility study with only 30 participants. The procedure may not be as effective as open surgery, and risks like premature rupture of membranes or preterm labor remain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2017

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

Chiari malformation Chiari malformation type II Congenital Abnormalities myelomeningocele neural tube defect neural tube defects, susceptibility to spina bifida

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chiari malformation type 2 Congenital abnormality Myelomeningocele Neural tube defects Spina bifida Spinal dysraphism

Keyhole surgery in the womb could fix spina bifida with fewer risks

What the study statuses mean