Keyhole surgery in the womb: a new hope for spina bifida?
NCT ID NCT02390895
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested a new, less invasive surgical technique to repair spina bifida before birth. Seven pregnant women carrying babies with the condition underwent a fetoscopic procedure using small incisions and a camera. The goal was to see if the surgery was feasible and safe for both mother and child.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- endoscopic fetal surgery
- What this could lead to
- If successful, this could offer a less invasive option for prenatal spina bifida repair, potentially reducing complications for mother and baby.
- What could go wrong
- This was a very small feasibility study with only 7 participants, so results may not apply broadly. The procedure carries risks like preterm birth and infection.
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
-
7 people
The number who actually took part.
- Started
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May 2017
- Finished
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Jul 2022
- Lead sponsor
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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
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18 years and older
- Sex
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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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient \> 18 years old, with an assumption by health insurance, understanding and speaking French * A term \< or = 26 +0 weeks gestational age * Single-Pregnancy * Myelomeningocele with higher-level defect between S1 and T1 * Arnold Chiari anomaly * No associated anomaly or chromosic anomaly Exclusion Criteria: * severe foetal kyphoscoliosis associated * Increased risk of preterm birth: cervical length \<15 mm, history of at least 2 late miscarriages, existing premature rupture of membrane * placenta previa, accreta or placental abruption * Maternal obesity with BMI\> 35 * Uterine anomalies : large interstitial uterine fibroid, uterine malformation * maternal infection with a foetal transmission risk: HIV, HBV, HCV * Maternal contradiction in surgery or anesthesia * poor social status and/or social isolation * impossible post-surgery follow-up * want to have a medical pregnancy termination
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hôpital Necker Enfants Malades
Paris, 75015, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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