Congenital Diaphragmatic Hernia Clinical Trial
Official title:
Qualitative In-depth Interviews With Women and Their Partners Concerning the Acceptability of Fetal Surgery
NCT number | NCT03788122 |
Other study ID # | S61586 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2018 |
Est. completion date | March 2020 |
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | March 2020 |
Est. primary completion date | March 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospital Leuven | Leuven | |
United Kingdom | University College London Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen Leuven | University College, London, Wellcome Trust |
Belgium, United Kingdom,
Adzick NS, Thom EA, Spong CY, Brock JW 3rd, Burrows PK, Johnson MP, Howell LJ, Farrell JA, Dabrowiak ME, Sutton LN, Gupta N, Tulipan NB, D'Alton ME, Farmer DL; MOMS Investigators. A randomized trial of prenatal versus postnatal repair of myelomeningocele. N Engl J Med. 2011 Mar 17;364(11):993-1004. doi: 10.1056/NEJMoa1014379. Epub 2011 Feb 9. — View Citation
Al-Maary J, Eastwood MP, Russo FM, Deprest JA, Keijzer R. Fetal Tracheal Occlusion for Severe Pulmonary Hypoplasia in Isolated Congenital Diaphragmatic Hernia: A Systematic Review and Meta-analysis of Survival. Ann Surg. 2016 Dec;264(6):929-933. Review. — View Citation
Cohen AR, Couto J, Cummings JJ, Johnson A, Joseph G, Kaufman BA, Litman RS, Menard MK, Moldenhauer JS, Pringle KC, Schwartz MZ, Walker WO Jr, Warf BC, Wax JR; MMC Maternal-Fetal Management Task Force. Position statement on fetal myelomeningocele repair. Am J Obstet Gynecol. 2014 Feb;210(2):107-11. doi: 10.1016/j.ajog.2013.09.016. Epub 2013 Sep 18. — View Citation
Deprest J, Nicolaides K, Done' E, Lewi P, Barki G, Largen E, DeKoninck P, Sandaite I, Ville Y, Benachi A, Jani J, Amat-Roldan I, Gratacos E. Technical aspects of fetal endoscopic tracheal occlusion for congenital diaphragmatic hernia. J Pediatr Surg. 2011 Jan;46(1):22-32. doi: 10.1016/j.jpedsurg.2010.10.008. — View Citation
Farmer DL, Thom EA, Brock JW 3rd, Burrows PK, Johnson MP, Howell LJ, Farrell JA, Gupta N, Adzick NS; Management of Myelomeningocele Study Investigators. The Management of Myelomeningocele Study: full cohort 30-month pediatric outcomes. Am J Obstet Gynecol. 2018 Feb;218(2):256.e1-256.e13. doi: 10.1016/j.ajog.2017.12.001. Epub 2017 Dec 12. — View Citation
Johnson MP, Bennett KA, Rand L, Burrows PK, Thom EA, Howell LJ, Farrell JA, Dabrowiak ME, Brock JW 3rd, Farmer DL, Adzick NS; Management of Myelomeningocele Study Investigators. The Management of Myelomeningocele Study: obstetrical outcomes and risk factors for obstetrical complications following prenatal surgery. Am J Obstet Gynecol. 2016 Dec;215(6):778.e1-778.e9. doi: 10.1016/j.ajog.2016.07.052. Epub 2016 Aug 2. — View Citation
Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017 Jan 26;17(1):88. doi: 10.1186/s12913-017-2031-8. — View Citation
Ville Y. Fetal therapy: practical ethical considerations. Prenat Diagn. 2011 Jul;31(7):621-7. doi: 10.1002/pd.2808. Epub 2011 Jun 10. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prospective acceptability of fetal surgery in the context of Myelomeningocele and Congenital Diaphragmatic Hernia. | Qualitative methodology. Prospective acceptability, as perceived by prospective parents eligible for fetal surgery, assessed by in-depth face-to face interviews. | After evaluation and counseling, if applicable, before undergoing fetal surgery. | |
Primary | Concurrent acceptability of fetal surgery in the context of Myelomeningocele and Congenital Diaphragmatic Hernia. | Qualitative methodology. Concurrent acceptability, as perceived by prospective parents eligible for fetal surgery, assessed by in-depth face-to face interviews. | After fetal surgery, within 7 days after surgery. | |
Primary | Retrospective acceptability of fetal surgery in the context of Myelomeningocele and Congenital Diaphragmatic Hernia. | Qualitative methodology. Retrospective acceptability, as perceived by prospective parents eligible for fetal surgery, assessed by in-depth face-to face interviews. | Three months after birth of the baby, or three months after termination of the pregnancy. |
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