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

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.

Study Overview

• Status: Recruiting
• Conditions: Myelomeningocele
• Intervention / Treatment: Other: Semi-structured interviews with a psychologist

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.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lucie GILBAUD, MD; Phone Number: 00 33 6 31 82 32 71; Email: lucie.guilbaud@aphp.fr

Study Locations

• France
  • Paris, France, 75012
    • Recruiting
    • Service de Médecine Foetale Hôpital Armand Trousseau
    • Contact: Lucie GILBAUD, MD; Phone Number: 00 33 6 31 82 32 71; Email: lucie.guilbaud@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Parents of children operated on in utero; Semi-structured interviews with a psychologist	Other: Semi-structured interviews with a psychologist; Semi-directed interviews using an interview guide on different themes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Studying the experience of couples who have chosen fetal surgery	Semi-structured interviews with a psychologist	up to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigate the decision-making factors that contributed to the choice of prenatal surgery	Semi-structured interviews with a psychologist	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	Semi-structured interviews with a psychologist	Up to 18 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Parents; Psychology; fetal myelomeningocele
• Additional Relevant MeSH Terms: Nervous System Diseases; Congenital Abnormalities; Nervous System Malformations; Neural Tube Defects; Spinal Dysraphism; Meningomyelocele; Spina Bifida Cystica
• Other Study ID Numbers: APHP230369

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No