RecruitingNAINTERVENTIONAL

Fetal Surgery Interview Study: Parental Perceptions of Fetal Surgery

This study aims to understand parents' thoughts and feelings about their unborn baby undergoing surgery for conditions such as spina bifida (myelomeningocele) or a problem with the baby's diaphragm (congenital diaphragmatic hernia). When doctors diagnose these conditions, parents face difficult choices, including whether to have surgery for the baby in the womb. This surgery might improve the baby's health after birth but also carries risks for both mother and baby, like early delivery. The study will involve in-depth interviews with parents at different stages of their journey to understand if they find these advanced surgical treatments acceptable. It will explore what influences their decisions and how they cope with such a complex medical situation.

At a glance

Status

Recruiting

Phase

Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrolment target

Start

01 Jul 2018

Estimated completion

01 Feb 2026

Fetal Surgery Myelomeningocele Congenital Diaphragmatic Hernia

What is this study about?

When a baby is diagnosed before birth with certain serious conditions, like spina bifida or a problem with their diaphragm, parents often face very difficult decisions. Doctors might suggest different paths, which could include continuing with the pregnancy as usual, considering ending the pregnancy, or, in some specific cases, offering surgery for the baby while still in the womb – known as fetal surgery.

Fetal surgery aims to help improve a baby's health or outcomes after birth. For example, it might help reduce some complications of spina bifida or improve lung development for babies with a diaphragmatic issue. However, this type of surgery is very complex and carries risks. These risks can include things like the mother's waters breaking early, infection, or, most importantly, the baby being born much too soon. Being born very early can lead to its own serious health problems for the baby.

Because these decisions are so personal and come with significant hopes and worries, this study wants to listen to parents' experiences. It aims to understand how mothers and their partners feel about fetal surgery for conditions like spina bifida (myelomeningocele) and a specific type of diaphragm problem (congenital diaphragmatic hernia). By talking with parents through detailed interviews, the researchers hope to learn what parents consider acceptable when making such profound medical choices for their unborn child. Your insights will help future families facing similar situations and guide medical teams in how they provide support and information.

Key takeaways

This study explores parents' feelings about unborn baby surgery.
It focuses on spina bifida and a diaphragm problem.
Participation involves sharing your experiences through interviews.
No medical treatments are given as part of the study.
Your insights can help improve support for future families.

Who may be eligible?

This study is looking for expectant parents who are considering or have chosen fetal surgery for their baby's condition. Specifically, you would be eligible if your baby has been diagnosed with either spina bifida (myelomeningocele) and open fetal surgery has been discussed, or a congenital diaphragmatic hernia for which keyhole surgery (Fetoscopic Endoluminal Tracheal Occlusion, or FETO) is being considered.

To join, mothers and their partners must be aged between 18 and 65 years. It's also important that you can understand and speak English well enough to take part in detailed conversations, or the local language if you are elsewhere.

If you meet these general criteria and are willing to share your experiences through interviews, you could be a valuable participant in this research. The study aims to gather perspectives directly from those going through this unique journey.

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.

Is my baby diagnosed with spina bifida (myelomeningocele)?
Is my baby diagnosed with a congenital diaphragmatic hernia?
Am I (or my partner) between 18 and 65 years old?
Can I communicate in English or the local language?
Am I considering or have had fetal surgery for my baby's condition?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be invited to participate in in-depth interviews. These interviews are designed to be a conversation where you can openly share your thoughts, feelings, and experiences about your baby's diagnosis and the decision-making process around fetal surgery. Each interview will be face-to-face and will be scheduled at key moments during your journey.

For example, the first interview might happen after you've had a detailed discussion with your doctors about all your treatment options, but before any surgery takes place. If you decide to go ahead with fetal surgery, there will be another interview shortly after the procedure, while you are still in the hospital. Finally, there will be a follow-up interview about 12 weeks after your baby is born, or after the pregnancy has ended, regardless of the outcome. The total duration of your participation will depend on these stages of your pregnancy and baby's birth.

Potential risks and benefits

While there aren't direct medical benefits from participating in this study, your involvement can provide invaluable insights that will help doctors and other healthcare professionals better understand parents' needs and concerns when considering complex fetal surgeries. This could lead to improved support and information for other families in the future. There are no notable risks to your physical health, but discussing sensitive and emotional topics could be challenging for some. You are in control of what you share and can choose not to answer any questions you're uncomfortable with. You are also free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospital Leuven
Verified postcode
Leuven, Belgium· Recruiting
University College London Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What kind of medical conditions are being looked at?

This study focuses on parents whose babies have been diagnosed with spina bifida (myelomeningocele) or a problem with their diaphragm (congenital diaphragmatic hernia) before birth.

What will I have to do if I take part?

You will be asked to have detailed, face-to-face interviews at different stages of your pregnancy journey. These interviews are for you to share your thoughts and feelings.

Are there any medical procedures involved in this study?

No, this study does not involve any medical procedures or treatments. It's purely about understanding your experiences and perspectives through interviews.

Who can join this study?

Mothers and their partners aged 18 to 65 years old, who are considering or have had fetal surgery for their baby's condition, are eligible. You also need to be able to communicate in English or the local language.

Will my personal information be kept private?

Yes, all your personal information and what you share in the interviews will be treated with the strictest confidence and used only for research purposes.

How to find out more

Jan Deprest, Professor

jan.deprest@uzleuven.be +3216 34 42 11 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.