Fetal Surgery Interview Study: Parental Perceptions of Fetal Surgery

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

Interventions

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.

Sponsors & Collaborators

• University College, London

  collaborator OTHER

• Wellcome Trust

  collaborator OTHER

• Universitaire Ziekenhuizen KU Leuven

  lead OTHER

Principal Investigators

• Jan Deprest, Professor · Universitaire Ziekenhuizen KU Leuven

• Neil Marlow · University College London Hospital

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-07-01

Primary Completion

2025-11-01

Completion

2026-02-01

Countries

• Belgium
• United Kingdom

Study Locations