NCT03788122 Fetal Surgery Interview Study: Parental Perceptions of Fetal Surgery
| NCT ID | NCT03788122 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Fetal Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2018-07-01 |
| Primary Completion | 2025-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2018-07-01 with a primary completion date of 2025-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 hernia (CDH). Following accurate diagnosis of a congenital malformation such as MMC or CDH, prospective parents face a range of uncertainties regarding the future of their unborn child, and the options provided require major ethical considerations. In the situation under study, termination of pregnancy may be for some parents an alternative option to expectant prenatal management. Fetal therapy provides a tantalising third option for some, where procedures are undertaken to reduce the likelihood of a more complicated neonatal course, potentially improving long term outcome, but at risk of amniotic fluid leakage, infection and most importantly very preterm delivery, itself associated with significant neonatal mortality and morbidity and long-term consequences. Balancing these competing risks is challenging. For an intervention to be effective it also needs to be acceptable to women and their families. "Acceptability" can be defined as a multi-faceted construct that reflects the extent to which people delivering or receiving a healthcare intervention consider it to be appropriate, based on anticipated or experienced cognitive and emotional responses to the intervention. With this study it is the aim to assess how women (and their partners) perceive the acceptability of a fetal surgical intervention for MMC and CDH. Participants will be asked to share their thoughts, views, feelings and experiences with regards to the decision to participate in fetal surgery. Data are collected by the use of in-depth face-to-face interviews. In-depth interviews are used to understand the participant's perspectives and perceptions of a situation they are in. It explicitly includes participants interpretation and understanding of an event The interviews will be held in two or three moments in time (for parents opting for fetal surgery, there will be one additional interview, after the intervention while admitted in hospital): after counselling for options, but before eventual intervention; for intervention group shortly after the intervention, and 12 weeks after birth of the baby, or termination of pregnancy.
Eligibility 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)
Contact & Investigator
Jan Deprest, Professor
PRINCIPAL INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Frequently Asked Questions
Who can join the NCT03788122 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Fetal Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03788122 currently recruiting?
Yes, NCT03788122 is actively recruiting participants. Contact the research team at jan.deprest@uzleuven.be for enrollment information.
Where is the NCT03788122 trial being conducted?
This trial is being conducted at Leuven, Belgium, London, United Kingdom.
Who is sponsoring the NCT03788122 clinical trial?
NCT03788122 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Jan Deprest, Professor at Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 40 participants.