Status:
RECRUITING
Fetal Surgery Interview Study: Parental Perceptions of Fetal Surgery
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
University College, London
Wellcome Trust
Conditions:
Fetal Surgery
Myelomeningocele
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Open maternal-fetal surgery is currently used on fetuses with myelomeningocele (MMC). Fetoscopic or minimal access fetal surgery is also being used to treat fetuses with congenital diaphragmatic herni...
Detailed Description
1. Background and rationale Fetal surgery is a highly technical procedure carried out by only a few specialised teams around the world. Fetal surgery improves outcomes for key conditions, but at signi...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03788122
Start Date
July 1 2018
End Date
February 1 2026
Last Update
July 1 2024
Active Locations (2)
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1
University Hospital Leuven
Leuven, Belgium, 3000
2
University College London Hospital
London, United Kingdom