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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
Sponsor:
Collaborators:
University College, London
Wellcome Trust
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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.


Condition or disease Intervention/treatment Phase
Fetal Surgery Myelomeningocele Congenital Diaphragmatic Hernia Other: In-depth interview Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Contacts
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Contact: Jan Deprest, Professor +3216 34 42 11 ext 44211 jan.deprest@uzleuven.be
Contact: Neeltje Crombag, Dr +3216 34 52 22 ext 45222 neeltje.crombag@kuleuven.be

Locations
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Belgium
University Hospital Leuven Recruiting
Leuven, Belgium, 3000
Contact: Jan Deprest, Professor    +3216 34 42 11    jan.deprest@uzleuven.be   
Contact: Neeltje Crombag, Dr    +3216 34 52 22    neeltje.crombag@kuleuven.be   
United Kingdom
University College London Hospital Recruiting
London, United Kingdom
Contact: Neil Marlow, Professor    +44(0)2076790834    n.marlow@ucl.ac.uk   
Contact: Anna David, Professor    +44(0)2076796060    a.david@ucl.ac.uk   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
University College, London
Wellcome Trust
Investigators
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Principal Investigator: Jan Deprest, Professor Universitaire Ziekenhuizen Leuven
Principal Investigator: Neil Marlow University College London Hospital

Publications:

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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03788122    
Other Study ID Numbers: S61586
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitaire Ziekenhuizen Leuven:
Acceptability
Qualitative research
Patient Perspectives
Additional relevant MeSH terms:
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Meningomyelocele
Spina Bifida Cystica
Hernias, Diaphragmatic, Congenital
Hernia, Diaphragmatic
Hernia
Pathological Conditions, Anatomical
Congenital Abnormalities
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Spinal Dysraphism