Exploring the experiences of parents after fetal surgery for myelomeningocele
In Utero Surgery for Fetal Myelomeningocele: Decision-making Mechanisms and Psychological Impact of Prenatal Therapy
This study is trying to understand how parents feel and what decisions they make before and after having surgery on their unborn baby to fix myelomeningocele.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris, Paris) |
| Trial ID | NCT06796972 on ClinicalTrials.gov |
What this trial studies
This study investigates the decision-making processes and psychological impacts on couples who have opted for in utero surgery to repair myelomeningocele in their fetus. It involves semi-structured interviews with both mothers and fathers, conducted by psychology students, to gather qualitative and quantitative data on their experiences before and after the surgery. The aim is to understand the factors influencing their choice and the emotional and psychological effects of the intervention. The study will include couples who have undergone either open surgery or fetoscopy.
Who should consider this trial
Good fit: Ideal candidates are mothers and adult co-parents of children who have undergone in utero surgery for myelomeningocele, whose child is at least 6 months old.
Not a fit: Patients who are under guardianship, deprived of liberty, or unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the psychological needs of parents facing complex prenatal decisions, potentially improving support and care for these families.
How similar studies have performed: While few studies have focused on this specific area, the qualitative approach to understanding parental experiences in similar contexts has shown promise in other medical fields.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Paris, Paris
- Service de Médecine Foetale Hôpital Armand Trousseau — Paris, Paris, France (Recruiting)
Study contacts
- Study coordinator: Lucie GILBAUD, MD
- Email: lucie.guilbaud@aphp.fr
- Phone: 00 33 6 31 82 32 71
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.