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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Patient under State Medical Aid

Trial design

Design model

Single group

Treatments tested in this trial

  • Semi-structured interviews with a psychologist

    Other intervention

    Semi-directed interviews using an interview guide on different themes

Treatment groups

44 Participants
are divided into 1 treatment group
Group A: Parents of children operated on in uteroOther 1 intervention

Trial outcomes

Primary outcomes

1

Studying the experience of couples who have chosen fetal surgery

Semi-structured interviews with a psychologist

Time frame
up to 18 months

Secondary outcomes

1

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

Semi-structured interviews with a psychologist

Time frame
Up to 18 months
2

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

Time frame
Up to 18 months

Other outcomes

Sponsors and contacts

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