Fetal Exposure Study (FES): Understanding Clinical Teratogen Syndromes
Research type
Research Study
Full title
Fetal Exposure Study (FES): Understanding Clinical Teratogen Syndromes
IRAS ID
327640
Contact name
Rebecca Bromley
Contact email
Sponsor organisation
The University of Manchester
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
Certain medications, when used at a stage in pregnancy when important parts of a baby’s body or brain are developing, can lead to an increased risk of health and developmental difficulties that may only become apparent during childhood. This study will invite individuals exposed to certain medications, along with their parents/carers, to take part in a project to improve our understanding of the problems certain medications can cause if taken during pregnancy, the NHS care needed by children and adults who are affected, and how to improve collection of this information in the future.
Using an observational, cross-sectional design Study 1 will recruit exposed individuals and their families to investigate the clinical features of multiple possible teratogen syndromes, using newly collected data (Part A: 0-16 years 11 months) and clinical assessment data previously collected via routine NHS care (Part B: no age limit). Additionally, we will invite individuals (over 15 years) with Fetal Valproate Spectrum Disorder (Study 2) and, where relevant, their parents/carers to talk to a researcher about their experiences of diagnosis and clinical management, to inform future service development.
For participants who complete both Study 1 and 2, participation will be completed within 3 months of recruitment. In-person neurodevelopmental assessments (Study 1) will be completed at a location of the participant’s choosing (e.g. home visit, participating NHS site, school). Parents will complete a set of questionnaires about the participating child/young person at this appointment. Study 2 interviews will take place online (e.g. zoom/teams).
The results of these studies will improve our understanding about the health and developmental features associated with these medications and the clinical and other care needs of individuals who have been affected by an exposure in the womb to a medication, supporting the development of suitable healthcare pathways in the future.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
23/LO/0599
Date of REC Opinion
8 Aug 2023
REC opinion
Further Information Favourable Opinion