Fetal Surgery Interview Study: Parental Perceptions of Fetal Surgery

NCT03788122 | Recruiting

• 1 other identifier: S61586
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 2

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.

Conditions

Fetal Surgery; Myelomeningocele; Congenital Diaphragmatic Hernia

Keywords

Acceptability; Qualitative research; Patient Perspectives

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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.

Study Arms (1)

Parents eligible for fetal surgery

OTHER

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

Interventions

In-depth interview OTHER

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.

Parents eligible for fetal surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• University College, London: collaborator
• Wellcome Trust: collaborator

Study Sites (2)

University Hospital Leuven

Leuven, 3000, Belgium

RECRUITING

University College London Hospital

London, United Kingdom

RECRUITING

Related Publications (8)

• 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.

  PMID: 24055581 BACKGROUND

• 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.

  PMID: 21238635 BACKGROUND

• Ville Y. Fetal therapy: practical ethical considerations. Prenat Diagn. 2011 Jul;31(7):621-7. doi: 10.1002/pd.2808. Epub 2011 Jun 10.

  PMID: 21660998 BACKGROUND

• 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.

  PMID: 21306277 BACKGROUND

• 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. doi: 10.1097/SLA.0000000000001675.

  PMID: 26910202 BACKGROUND

• 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.

  PMID: 28126032 BACKGROUND

• 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.

  PMID: 29246577 BACKGROUND

• 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.

  PMID: 27496687 BACKGROUND

MeSH Terms

Conditions

Meningomyelocele; Hernias, Diaphragmatic, Congenital

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan Deprest, Professor

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

• Neil Marlow

  University College London Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Deprest, Professor

CONTACT

+3216 34 42 11; jan.deprest@uzleuven.be

Neeltje Crombag, Dr

CONTACT

+3216 34 52 22; neeltje.crombag@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 27, 2018
• Study Start: July 1, 2018
• Primary Completion: November 1, 2025
• Study Completion: February 1, 2026
• Last Updated: July 1, 2024

Record last verified: 2024-06

Locations

GB (1); BE (1)