FSSB database
Research type
Research Database
IRAS ID
255969
Contact name
Anna David
Contact email
Research summary
Fetal Surgery Spina Bifida Database
REC name
HSC REC B
REC reference
21/NI/0099
Date of REC Opinion
17 Jun 2021
REC opinion
Favourable Opinion
Data collection arrangements
This Database will collect information on women who are referred to our unit for consideration of fetal surgery for spina bifida. We will collect data on maternal demographics, fetal assessment by imaging using ultrasound and MRI, fetal surgery events, delivery, maternal, neonatal and paediatric outcomes. Data will be collected by clinical and research staff and will be stored on an NHS compatible password protected database. After surgery and birth, babies will have follow up at Great Ormond Street Hospital for Children who are part of our Fetal Surgery team and NHS England commissioned service. Babies are also likely to be followed up at their local paediatric neurosurgical unit. We will therefore also collect data on maternal, fetal and neonatal/paediatric outcomes from other NHS Trust clinical electronic databases and/or case notes at other NHS Trusts local to their home where these mothers and their children are seen. In case that we cannot retrieve information from other NHS Trusts, we will contact the parents via email and/or mail and /or telephone call to obtain information of maternal, neonatal and pediatric outcomes.
Research programme
The Centre for Prenatal Therapy at UCLH was set up in collaboration with UZ Leuven, Belgium and has now been commissioned by NHS England Specialist Commissioning as one of two Fetal Surgery Centres, the other being UZ Leuven, to provide fetal surgery for women whose fetus has spina bifida. This surgical option is now recognised as first-line treatment for some selected fetuses with spina bifida, as it improves long term outcomes for the baby (significantly improved motor, bladder and bowel function). Data is still needed however on optimal patient selection and long term outcomes after surgery. The research program will therefore be studying the fetal imaging, surgery and neonatal/paediatric and maternal long term outcomes.
Research database title
Fetal Surgery Spina Bifida Database
Establishment organisation
University College London Hospital NHS Foundation Trust
Establishment organisation address
235 Euston Rd, Fitzrovia, London
NW1 2BU