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

NCT ID: NCT06796972

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-23
• Study Completion Date: 2026-03-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Parents of children operated on in utero

Semi-structured interviews with a psychologist

Group Type: OTHER

Semi-structured interviews with a psychologist

Intervention Type: OTHER

Semi-directed interviews using an interview guide on different themes

Interventions

Semi-structured interviews with a psychologist

Semi-directed interviews using an interview guide on different themes

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Service de Médecine Foetale Hôpital Armand Trousseau

Paris, Paris, France

Site Status: RECRUITING

Countries

France

Central Contacts

Lucie GILBAUD, MD

Role: CONTACT

lucie.guilbaud@aphp.fr

00 33 6 31 82 32 71

Facility Contacts

Lucie GILBAUD, MD

Role: primary

lucie.guilbaud@aphp.fr

00 33 6 31 82 32 71

Other Identifiers

APHP230369

Identifier Type: -

Identifier Source: org_study_id