Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06796972

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-01-28

44

Participants Needed

1

Research Sites

74 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Mothers and adult co-parents of the child with myelomeningocele operated in utero, who have signed informed consent
  • Mothers aged 18 years or older at the time of fetal surgery for in utero repair by laparotomy and hysterotomy
  • Child affected by the surgery is at least 6 months old
  • French-speaking participants
  • Participants without severe psychiatric disorders altering reality
  • Participants affiliated to a social security system
Not Eligible

You will not qualify if you...

  • Patients under guardianship, curatorship, deprived of liberty, or unable to sign informed consent
  • Patients under State Medical Aid

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Service de Médecine Foetale Hôpital Armand Trousseau

Paris, Paris, France, 75012

Actively Recruiting

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Research Team

L

Lucie GILBAUD, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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