Transfer of Antiepileptics in Breastmilk and Infant Feeding Decisions
Research type
Research Study
Full title
Antiepileptic drugs - Salivary testing of infants with breastmilk exposure and the decision making processes of women with epilepsy regarding infant feeding
IRAS ID
202971
Contact name
Marlene Sinclair
Contact email
Sponsor organisation
University of Ulster
Duration of Study in the UK
1 years, 2 months, 1 days
Research summary
Epilepsy is the most common serious neurological condition worldwide, with 275,000 women in the UK being affected (Epilepsy Action 2014). The Epilepsy Society (2013) recommends women with epilepsy breastfeed, however, women often get conflicting information from healthcare providers regarding breastfeeding due to a lack of evidence about medication transfer into breastmilk.
Study aim: This study aims to provide necessary evidence on the transfer of medication into breastmilk so that both women and health professionals will be able to make evidence-informed decisions.
The study proposed involves a range of methods to collect the required information from pregnant women who are taking antiepileptic drugs (AEDS). In Northern Ireland approximately 150 women with epilepsy give birth each year and the numbers vary across Trusts. Therefore this study will be conducted across three Trusts in Northern Ireland. Eligible women who meet the inclusion criteria will be invited to take part in the study at their antenatal booking clinic.
They will be asked to take part in three short interviews (16-20 weeks, 30 weeks and 3 weeks postnatally). Women will also be asked to provide two samples of breastmilk; the first sample will be collected 72-120 hours after birth, and if breastfeeding, the second sample will be collected three weeks postnatally. In addition, we will collect salivary samples from the babies at the same time points to measure the level of medication transferring to the baby. The final data collection will be an online survey sent to all women with epilepsy in the UK to explore the impact of the scientific evidence on their infant feeding decision making.
Data will be organised using NVivo and analysed useing SPSS. The findings from this study will be disseminated widely using open access publications and relevant websites for specialist practitioners and consumer groups.REC name
HSC REC B
REC reference
16/NI/0227
Date of REC Opinion
15 Dec 2016
REC opinion
Further Information Favourable Opinion