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

Recruiting now · Not applicable

Conditions studied: Myelomeningocele

In brief

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.

Key facts

Study ID

NCT06796972

Run by

Assistance Publique - Hôpitaux de Paris

People needed

44

Starts

2024-09-23

Expected to finish

2026-03-01

Last updated by the study team

2025-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Service de Médecine Foetale Hôpital Armand Trousseau — Paris, Paris, France (enrolling)

Full record on ClinicalTrials.gov

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