Fetal Surgery Interview Study: Parental Perceptions of Fetal Surgery
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|ClinicalTrials.gov Identifier: NCT03788122|
Recruitment Status : Recruiting
First Posted : December 27, 2018
Last Update Posted : December 27, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Fetal Surgery Myelomeningocele Congenital Diaphragmatic Hernia||Other: In-depth interview||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Qualitative In-depth Interviews With Women and Their Partners Concerning the Acceptability of Fetal Surgery|
|Actual Study Start Date :||July 1, 2018|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
Parents eligible for fetal surgery
Parents eligible for fetal surgery will undergo two or three in-depth face-tot-face interviews, to determine their perception of acceptability of fetal surgery.
Other: In-depth interview
The 'intervention' administered to this group of participants are two or three in-depth interviews (average 30-60 m minutes per interview) on their experiences, views, feelings and thoughts (perceptions) regarding acceptability of the fetal surgery.
- Prospective acceptability of fetal surgery in the context of Myelomeningocele and Congenital Diaphragmatic Hernia. [ Time Frame: After evaluation and counseling, if applicable, before undergoing fetal surgery. ]Qualitative methodology. Prospective acceptability, as perceived by prospective parents eligible for fetal surgery, assessed by in-depth face-to face interviews.
- Concurrent acceptability of fetal surgery in the context of Myelomeningocele and Congenital Diaphragmatic Hernia. [ Time Frame: After fetal surgery, within 7 days after surgery. ]Qualitative methodology. Concurrent acceptability, as perceived by prospective parents eligible for fetal surgery, assessed by in-depth face-to face interviews.
- Retrospective acceptability of fetal surgery in the context of Myelomeningocele and Congenital Diaphragmatic Hernia. [ Time Frame: Three months after birth of the baby, or three months after termination of the pregnancy. ]Qualitative methodology. Retrospective acceptability, as perceived by prospective parents eligible for fetal surgery, assessed by in-depth face-to face interviews.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788122
|Contact: Jan Deprest, Professor||+3216 34 42 11 ext firstname.lastname@example.org|
|Contact: Neeltje Crombag, Dr||+3216 34 52 22 ext email@example.com|
|University Hospital Leuven||Recruiting|
|Leuven, Belgium, 3000|
|Contact: Jan Deprest, Professor +3216 34 42 11 firstname.lastname@example.org|
|Contact: Neeltje Crombag, Dr +3216 34 52 22 email@example.com|
|University College London Hospital||Recruiting|
|London, United Kingdom|
|Contact: Neil Marlow, Professor +44(0)2076790834 firstname.lastname@example.org|
|Contact: Anna David, Professor +44(0)2076796060 email@example.com|
|Principal Investigator:||Jan Deprest, Professor||Universitaire Ziekenhuizen Leuven|
|Principal Investigator:||Neil Marlow||University College London Hospital|