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Outcomes of maternal epilepsy and antiepileptic medications during pregnancy (PREPArE)

Safe People

Organisation name

University of Bristol

Organisation sector

Academic Institute

Applicant name(s)

Dheeraj Rai - Chief Investigator - University of BristolPaul Madley-Dowd - Corresponding Applicant - University of Bristol - Collaborator -Caichen Zhong - Collaborator - Drexel UniversityFlorence Martin - Collaborator - University of BristolHarriet Forbes - Collaborator - University of BristolJessica Rast - Collaborator - Drexel UniversityKristen Lyall - Collaborator - Drexel UniversityNeil Davies - Collaborator - University of Bristol

Safe Projects

Project ID

CPRD695

Lay summary

Epilepsy is the most common serious neurological disorder. Antiepileptic drugs are used to treat epilepsy and are also used as mood stabilisers for some mental disorders such as bipolar disorder. While these drugs may prevent harm to the mother, they may harm the fetus. We will study the effects of taking these drugs, and the underlying conditions for which they are prescribed during pregnancy. Our study will answer four questions. First: what are the patterns of antiepileptic drug prescribing across the pregnancy period? Second: what are the risks of adverse maternal, pregnancy and child outcomes among women with epilepsy and other indications of antiepileptic prescribing? Third: does use of these drugs during pregnancy influence the risk of adverse maternal, child and pregnancy outcomes? Fourth: are our results robust to the various assumptions made by our analysis techniques. Our results will help doctors and patients make informed decisions about using these medicines.

Technical summary

Antiepileptic and mood stabiliser medications (collectively abbreviated as AEDs) refer to an overlapping group of drugs prescribed for a range of neuropsychiatric conditions including epilepsy and bipolar disorder. Their use in pregnancy is often necessary to reduce harms to the mother. There is little robust evidence for the maternal and fetal safety profile of many AEDs although some drugs such as sodium valproate are known to be teratogenic.

Latest approval date

22/03/2021

Safe Data

Dataset(s) name

CPRD Mother-Baby Link

HES Accident and Emergency

HES Admitted Patient Care

HES Outpatient

Mental Health Services Data Set (MHSDS)

ONS Death Registration Data

Patient Level Index of Multiple Deprivation

Practice Level Index of Multiple Deprivation

Pregnancy Register

Safe Setting

Access type

Release