Surgery before birth may ease spina bifida damage
NCT ID NCT01983345
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested a surgery performed before birth to repair a spinal defect called myelomeningocele, a severe form of spina bifida. The goal was to see if fixing the spine in the womb could reduce brain problems and nerve damage after birth. 38 pregnant women carrying fetuses with this condition took part. The surgery aims to lower the risk of fluid buildup in the brain and improve leg movement.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- prenatal surgical repair of fetal myelomeningocele
- What this could lead to
- If successful, this surgery could reduce the need for shunts and improve leg function in children born with spina bifida.
- What could go wrong
- This is a small, early-phase study with no control group, so results may not apply widely. Surgery carries risks for both mother and fetus, including preterm labor.
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
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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
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38 people
The number who actually took part.
- Started
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Jul 2014
- Finished
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Jul 2021
- 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
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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 of majority age, with an assumption by health insurance, understanding and speaking French * A term between 19 and 25 +6 weeks gestational age (not for control) * Single-Pregnancy * Normal fetal karyotype * Myelomeningocele with higher-level defect between S1 and T1 * Placenta not low-inserted or not covering * Fault-isolated ultrasound reference Exclusion Criteria: * Age under 18 years * Patient foreigner who understands not French * Multiple Pregnancy * Low Placenta inserted or covering * Severe kyphosis * Placental abruption * Fetal malformation unrelated to the existence of myelomeningocele (the existence of a malposition of one or both feet do not represent an exclusion criterion) * Increased risk of preterm birth: a history of preterm delivery before 37 weeks gestational age, cervical length \<26 mm before 26 weeks gestational age (not for control) * Bleeding active between 20 and 26 weeks gestational age (not for control) * Maternal obesity with BMI\> 35 (not for control) * History of uterine surgery involving the anterior surface of the uterus (not for control) * Maternal contradiction in surgery or general anesthesia (not for control)
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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
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Hopital Armand Trousseau, APHP
Paris, PARIS, 75012, France