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Clinical Trials in France / NCT06796972
Recruiting Not applicable

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

NCT06796972 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Not applicable
Started
2024-09-23
Last updated
2025-01-28

Condition(s) studied

Myelomeningocele

Investigational drug(s) / intervention(s)

Semi-structured interviews with a psychologist

Semi-structured interviews with a psychologist: Semi-directed interviews using an interview guide on different themes

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Studying the experience of couples who have chosen fetal surgery — up to 18 months
    Semi-structured interviews with a psychologist

Trial sites (1)

FacilityCityRegionStatus
Service de Médecine Foetale Hôpital Armand Trousseau Paris Paris Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06796972 on ClinicalTrials.gov ↗ ← All trials in France