Parental perceptions of fetal surgery Version 1.0
Research type
Research Study
Full title
Acceptability of fetal surgery. An investigation of the acceptability of fetal surgery as an option for the management of myelomeningocele and congenital diaphragmatic hernia
IRAS ID
239408
Contact name
Neil Marlow
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2018/06/178, UCL Data Protection
Duration of Study in the UK
1 years, 5 months, 8 days
Research summary
Research Summary
Fetal surgery is a highly technical procedure executed by only few specialised teams around the world. Open maternal-fetal surgery and endoscopy are currently used to repair lesions in fetuses with open spina bifida and congenital diaphragmatic hernia. Surgery on fetuses can contribute to potential pediatric improvements, but at significant procedure-related fetal and maternal risks.
- Spina bifida arises when, early in pregnancy, the spinal cord and spinal cord are to properly formed. It occurs in 4 in 10,000 pregnancies. Open spina bifida causes a large variety of effects, from mild to very severe. In the severest forms children are paraplegic, wheelchair-bound and may have hydrocephalus requiring an intra-ventricular shunt
- Congenital diaphragmatic hernia occurs in 1/2500 to 1/5000 of newborns. Due to a defect in the diaphragm formed during embryonic development, abdominal organs herniate through the defect into the cardiac cavity, interfering with lung growth, resulting in developmental arrest of both airways and vasculature.
The Guided Instrumentation for Fetal Therapy and Surgery(GIFT-surg) project, is designed to develop surgical tools and advanced imaging techniques, which when combined provides fetal surgeons with tools to make endoscopic fetal surgery safer and efficient, and consequently allowing more parents and babies to benefit from the intervention.
The extent to which people receiving a healthcare intervention consider it to be appropriate, based on emotional and cognitive responses to the intervention, is called acceptability. Acceptability is an essential consideration when designing, evaluating and implementing a healthcare intervention. The aim of this study to evaluate acceptability of fetal surgical interventions as perceived by affected women (and partners), by executing face-to face interviews in three European countries: United Kingdom, Belgium and Spain. At each non-UK site local permission to conduct the research is being sought in parallel.
The interview findings will be evaluated using qualitative thematics and form part of the formal evaluation of the effects of fetal intervention on the child and the family.
Summary of Results
This study explores the strategies parents employ when considering fetal surgery as an option for the management of spina bifida in their fetus. It has found that, despite the risks incurred, fetal surgery remains a highly acceptable intervention to those who opt for it.
The study, published in Prenatal Diagnosis, involved interviews with parents whose fetuses with spina bifida were eligible for fetal surgery. Prospective parents receiving an antenatal diagnosis of spina bifida often face uncertainties regarding the future of their unborn child and the options provided (including fetal surgery, postnatal management and the termination of pregnancy) pose major ethical challenges.While fetal surgery can improve medium and long-term neurological outcomes, it comes with significant risk to the baby and the mother, including the potential of premature membrane rupture, preterm delivery and rarely fetal death.
However, the research revealed that the acceptability of the intervention among parents remained high prior to and directly after the procedure, as well as 3-6 months postnatally. Parents’ expectations seemed to be realistic, yet were driven by hope of the best outcome. None of the study participants expressed regret about their decision at any stage and at the final interview, all of them were happy with their child’s outcome, which they reported as being often better than they hoped for.
The parents interviewed were often referred long-distance, or even to treatment abroad and a perceived break in the continuity of care between treatment centre and referral centre caused additional stress to an already intense pregnancy trajectory.
Some mothers were diagnosed with mental health issues after the birth of their baby, which they relate to events they experienced during their pregnancy. This suggests that women undergoing the procedure require appropriate follow-up and support to detect increased risks of mood and anxiety disorders. Notably, the parents who took part in this study - including those who were diagnosed with mental health issues - reported adjusting adequately to their new situation, regardless of the individual outcome.
The small group of study participants who opted for termination of pregnancy felt that fetal surgery offered insufficient certainty of substantial improvement in quality of life. The perceived severe impact of spina bifida drove their decision to end the pregnancy.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
18/SC/0475
Date of REC Opinion
25 Oct 2018
REC opinion
Favourable Opinion