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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
France
Service de Médecine Foetale Hôpital Armand Trousseau
RECRUITING
Paris
Contact Information
Primary
Lucie GILBAUD, MD
lucie.guilbaud@aphp.fr
00 33 6 31 82 32 71
Time Frame
Start Date: 2024-09-23
Estimated Completion Date: 2026-03
Participants
Target number of participants: 44
Treatments
Other: Parents of children operated on in utero
Semi-structured interviews with a psychologist
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov

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