Actively Recruiting
In Utero Surgery for Fetal Myelomeningocele: Decision-making and Psychological Impact of Prenatal Therapy
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-01-28
44
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on couples who have chosen to continue a pregnancy after a prenatal diagnosis of myelomeningocele, a spinal malformation in the fetus. The study explores the psychological experience and decision-making processes of these couples who opted for in utero surgery to repair the condition. It is a cross-sectional observational study using both qualitative and quantitative methods to understand the impact of this prenatal therapy. Participants include parents of children who underwent fetal surgery, either open surgery or fetoscopy, to repair myelomeningocele. The study involves semi-structured interviews conducted by psychologists and the completion of decision-making scales by each parent. These procedures are in addition to usual care and may influence the parents' care experience. During the study, mothers and fathers separately participate in interviews with psychologist researchers and complete questionnaires about their decision-making. The research team will study the couples' experiences up to 18 months after surgery, focusing on factors influencing their choices and the quality of information received when faced with the diagnosis. The study aims to provide insights into the psychological effects and decision processes surrounding fetal surgery for myelomeningocele.
CONDITIONS
Brief Title
In Utero Surgery for Fetal Myelomeningocele: Decision-making Mechanisms and Psychological Impact of Prenatal Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mothers and adult co-parents of children with myelomeningocele operated in utero who have signed informed consent
- Mothers aged 18 years or older at the time of fetal surgery
- Child affected by the surgery is at least 6 months old
- Ability to speak French
- No severe psychiatric disorder affecting relationship with reality
- Affiliated with a social security system
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - Up to 18 months
Participants take part in semi-structured interviews with a psychologist and complete decision-making scales to explore their experience and psychological impact of prenatal surgery.
1 to 2 visits depending on scheduling
Trial Site Locations
Total: 1 location
1
Service de Médecine Foetale Hôpital Armand Trousseau
Paris, Paris, France, 75012
Actively Recruiting
Research Team
L
Lucie GILBAUD, MD
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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