RecruitingNot ApplicableNCT06796972

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


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

44 participants

Start Date

Sep 23, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria2

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

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Interventions

OTHERSemi-structured interviews with a psychologist

Semi-directed interviews using an interview guide on different themes


Locations(1)

Service de Médecine Foetale Hôpital Armand Trousseau

Paris, Paris, France

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NCT06796972


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