In Utero Surgery for Fetal Myelomeningocele: Decision-making Mechanisms and Psychological Impact of Prenatal Therapy
This study explores how parents decide to have surgery while their baby is still in the womb for a condition called myelomeningocele (a severe form of spina bifida). This condition affects the baby's spine and spinal cord and can lead to complex disabilities. While womb surgery can help improve the baby's future health, it doesn't offer a complete cure and carries risks for both the baby and the mother. Researchers want to understand why parents make this choice and what their experiences are like, both before and after the surgery. They'll be talking to mothers and fathers through interviews with psychologists. The findings will help provide crucial insights into how families cope with such a difficult decision and the emotional impact of this special treatment.
At a glance
What is this study about?
Imagine finding out your baby has a serious condition called myelomeningocele, which is a severe form of spina bifida. This means their spinal cord hasn't developed properly, leading to potential challenges for their health and movement. Sometimes, surgery can be performed while the baby is still in the womb to help improve their outlook after birth. However, this surgery is not a cure, and it comes with risks for both the baby and the mother.
Because this is such a major decision, this study wants to look closely at what goes into a couple's choice to go ahead with this special surgery. We know that few studies have focused on this topic, especially from the parents' point of view. This research aims to fill that gap by understanding the experiences of parents who have already made this difficult choice.
By conducting in-depth interviews with mothers and fathers, the researchers will try to understand their feelings, their reasons, and how they coped with the decision and the surgery itself. This information is really important because it can help doctors and support groups better understand and support other families who might face similar situations in the future.
Key takeaways
- This study explores parents' experiences with womb surgery for spina bifida.
- It aims to understand why parents make this choice and how they feel afterwards.
- Participation involves interviews with psychologists.
- Your story can help other families in the future.
- Your privacy and choices are respected; you can withdraw anytime.
Who may be eligible?
This study is looking for mothers and fathers whose baby had a myelomeningocele (spina bifida) and had surgery while still in the womb. You must have been at least 18 years old at the time of the surgery, and your child should be at least 6 months old now. It's important that you can speak French to take part.
You can participate whether you had the 'open' surgery (called laparotomy and hysterotomy) or the 'keyhole' surgery (called fetoscopy). Both parents are welcome to take part, but you'll be interviewed separately. You should also be connected to a social security system. We can't include people who have severe mental health conditions that affect how they see reality, or those who legally can't agree to be part of a study, like if you're under guardianship or in prison.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you a mother or father whose baby had womb surgery for myelomeningocele?
- Were you at least 18 years old when the surgery took place?
- Is your child now at least 6 months old?
- Can you speak French?
- Do you not have a severe mental health condition that affects how you see reality?
- Are you connected to a social security system?
What does participation involve?
If you decide to take part, your involvement will be quite simple. You (and your partner, if they also choose to participate) will have an interview with a psychologist. This interview will be focused on your experiences and feelings related to your child's in-womb surgery for myelomeningocele. These interviews will be carried out by a psychologist and a psychology student who are part of the research team. Each parent will have their own separate interview. You'll also be asked to complete a short questionnaire about your decision-making. These interviews and questionnaires are the only extra things you'll be asked to do because of the study. This means there's no medication specifically for the study, no extra medical appointments, and no follow-up beyond the interview itself. The total time commitment will be for the interview and questionnaire.
Potential risks and benefits
Locations (1)
- Service de Médecine Foetale Hôpital Armand TrousseauVerified postcodeParis, France· Recruiting
Common questions
What is myelomeningocele?
It's a serious form of spina bifida where the baby's spinal cord doesn't close properly during pregnancy, leading to potential health issues.
What is 'in utero surgery'?
This is surgery performed on the baby while they are still inside the mother's womb, before they are born.
Will this study change my child's medical care?
No, this study is about understanding your experience, not about changing your or your child's current medical care.
Will my personal story be kept private?
Yes, all the information you share will be kept confidential and your identity will be protected.
How long will my involvement in the study last?
Your involvement will be limited to the interview and completing a decision questionnaire.
How to find out more
Lucie GILBAUD, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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