In Utero Surgery for Fetal Myelomeningocele: Decision-making Mechanisms and Psychological Impact of Prenatal Therapy
Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jan 22, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating the experiences and decision-making processes of parents who choose in utero surgery for their unborn child diagnosed with myelomeningocele, a serious spinal condition. The goal is to understand what influences their choice to undergo this surgery, how it impacts them emotionally, and what they go through both before and after the procedure. While this surgery can improve the child's future health, it also carries risks for both the baby and the mother.
To participate in the study, mothers and adult co-parents must be at least 18 years old, have had in utero surgery for their child’s myelomeningocele, and their child must be at least 6 months old. Both parents can join, but they will be interviewed separately. Participants should be able to speak French and not have any severe mental health issues that might affect their understanding. The trial is currently looking for volunteers, and it aims to provide valuable insights into the emotional and practical considerations faced by families dealing with this condition.
Gender
ALL
Eligibility 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
About Assistance Publique Hôpitaux De Paris
Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Paris, , France
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported