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In Utero Surgery for Fetal Myelomeningocele: Decision-making Mechanisms and Psychological Impact of Prenatal Therapy

RecruitingNAAges 18 Years - anyAllAssistance Publique - Hôpitaux de Paris
NCT06796972 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Semi-structured interviews with a psychologist
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Where

1 site
Service de Médecine Foetale Hôpital Armand Trousseau
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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