NCT06796972 In Utero Surgery for Fetal Myelomeningocele: Decision-making Mechanisms and Psychological Impact of Prenatal Therapy
| NCT ID | NCT06796972 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Myelomeningocele |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2024-09-23 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 44 participants in total. It began in 2024-09-23 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Myelomeningocele is a malformation of the spine and spinal cord, generally diagnosed prenatally, and responsible for a complex disability for the unborn child. In the event of continued pregnancy, in utero surgery can be performed to improve the prognosis of the children. This fetal therapy does not allow a cure and induces risks for the fetus, and for the mother, both during surgery and for her obstetric future. Currently, few studies have focused on the factors influencing the choice to resort to in utero surgery and the experience of patients and co-parents before and after this intervention. No qualitative study on the subject has been published to date.
Eligibility Criteria
Inclusion Criteria: * Mothers and adult co-parents of the child with MMC operated in utero, having signed informed consent. If both members of the couple have agreed to participate, they will be received separately. * Mother who had fetal surgery for in utero repair of a fetal myelomeningocele by laparotomy and hysterotomy aged 18 years or older at the time of surgery, and whose child affected by the surgery is at least 6 months old * Speaking French * Not presenting a severe psychiatric disorder altering the relationship with reality * Patient affiliated to a social security system Exclusion Criteria: * Patient under guardianship or curatorship, deprived of liberty or unable to sign informed consent to participate in the study * Patient under State Medical Aid
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06796972 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myelomeningocele. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06796972 currently recruiting?
Yes, NCT06796972 is actively recruiting participants. Contact the research team at lucie.guilbaud@aphp.fr for enrollment information.
Where is the NCT06796972 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06796972 clinical trial?
NCT06796972 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 44 participants.