Exploring parental views on fetal surgery options
Qualitative In-depth Interviews With Women and Their Partners Concerning the Acceptability of Fetal Surgery
This study talks to parents to see what they think about fetal surgery options for serious conditions in babies before they are born.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 2 sites (Leuven and 1 other locations) |
| Trial ID | NCT03788122 on ClinicalTrials.gov |
What this trial studies
This study investigates the perceptions of parents regarding fetal surgery for conditions such as myelomeningocele and congenital diaphragmatic hernia. Through in-depth interviews, the research aims to understand the uncertainties and ethical considerations faced by prospective parents when considering fetal therapy as an alternative to termination or expectant management. The study is part of a larger project aimed at improving the safety and efficiency of fetal surgery. By gathering qualitative data, the research seeks to inform clinical practices and enhance patient support.
Who should consider this trial
Good fit: Ideal candidates for this study are expectant parents eligible for fetal surgery procedures related to spina bifida or congenital diaphragmatic hernia.
Not a fit: Patients who are not eligible for the specified fetal surgery procedures or who cannot communicate in the required languages may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights that improve communication and decision-making for parents facing complex prenatal diagnoses.
How similar studies have performed: While fetal surgery has been studied, this qualitative approach focusing on parental perceptions is relatively novel and has not been extensively explored in previous research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women/partners eligible for one of the two fetal surgery procedures studied (open fetal surgery for spina bifida closure, tracheal balloon occlusion for congenital diaphragmatic hernia (Fetoscopic Endoluminal Tracheal Occlusion, FETO), as clinical care * Have given written informed consent for participation Exclusion: * Women less than 18 years or over 65 years of age * Partners less than 18 years or over 65 years of age * Women or their partners who are unable to communicate in either English or the local language (if different)
Where this trial is running
Leuven and 1 other locations
- University Hospital Leuven — Leuven, Belgium (Recruiting)
- University College London Hospital — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Jan Deprest, Professor — Universitaire Ziekenhuizen KU Leuven
- Study coordinator: Jan Deprest, Professor
- Email: jan.deprest@uzleuven.be
- Phone: +3216 34 42 11
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.