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

NCT06796972 | Recruiting

• 1 other identifier: APHP230369
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Myelomeningocele

Keywords

Psychology; fetal myelomeningocele; Parents

Outcome Measures

Primary Outcomes (1)

• Studying the experience of couples who have chosen fetal surgery

  Semi-structured interviews with a psychologist

  up to 18 months

Secondary Outcomes (2)

• Investigate the decision-making factors that contributed to the choice of prenatal surgery

  Up to 18 months

• Evaluate the quality of the information that couples received regarding the three possibilities proposed when faced with a prenatal diagnosis of myelomeningocele

  Up to 18 months

Study Arms (1)

Parents of children operated on in utero

OTHER

Semi-structured interviews with a psychologist

Other: Semi-structured interviews with a psychologist

Interventions

Semi-structured interviews with a psychologist OTHER

Semi-directed interviews using an interview guide on different themes

Parents of children operated on in utero

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient under guardianship or curatorship, deprived of liberty or unable to sign informed consent to participate in the study
• Patient under State Medical Aid

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de Médecine Foetale Hôpital Armand Trousseau

Paris, Paris, 75012, France

RECRUITING

MeSH Terms

Conditions

Meningomyelocele

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Lucie GILBAUD, MD

CONTACT

00 33 6 31 82 32 71; lucie.guilbaud@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: September 23, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)