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NCT Number: NCT06796972

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Médecine Foetale Hôpital Armand Trousseau

Paris, 75012, France

Location status: Recruiting

Location contact

Lucie GILBAUD, MD

CONTACT

[email protected]

00 33 6 31 82 32 71

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Semi-structured interviews with a psychologist

Other

Semi-directed interviews using an interview guide on different themes

Primary outcomes

  1. Studying the experience of couples who have chosen fetal surgery

    Time frame: up to 18 months

    Semi-structured interviews with a psychologist

Secondary outcomes

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

    Time frame: Up to 18 months

    Semi-structured interviews with a psychologist

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

    Time frame: Up to 18 months

    Semi-structured interviews with a psychologist

Study contacts

Contact information is provided by the study sponsor or research team.

Lucie GILBAUD, MD

CONTACT

[email protected]

00 33 6 31 82 32 71

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: PriumPsy

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2025
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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