NCT06796972

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study population corresponds to all couples who have chosen to continue the pregnancy in the face of a prenatal diagnosis of myelomeningocele in their fetus as well as to resort to in utero surgery to repair this malformation. In order to obtain the largest possible sample, the study will be offered to both couples who have had open surgery and those who have had fetoscopy. This study aims to investigate, a posteriori, the experience of couples who have chosen fetal surgery to repair a myelomeningocele. This is a study in clinical psychology, cross-sectional observational with an approach that will be mixed, qualitative and quantitative. In practice, the only procedures added by the research will consist of: * an interview between the mother of the child operated on in utero and a psychologist researcher-student pair in Master 2 of psychology * an interview between the father of the child operated on in utero and a psychologist researcher-student pair in Master 2 of psychology * the completion of a decision scale by each of the parents The presence of the interview with a psychologist not planned as part of the care may lead to the modification of the usual care of the parents.

Conditions

• Myelomeningocele

Interventions

Type	Name	Description
OTHER	Semi-structured interviews with a psychologist	Semi-directed interviews using an interview guide on different themes

Timeline

• Start date: 2024-09-23
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2025-01-28
• Last updated: 2025-01-28

Locations

1 site across 1 country: France