Objective To establish the relative risks of in utero exposure to lamotrigine (LTG), sodium valproate (NaV) and carbamazepine (CBZ) monotherapy for neurodevelopment.
Design Observational cohort study.
Patients and methods The study group consisted of children in Northern Ireland aged 9–60 months born to mothers who had enrolled with the UK Epilepsy and Pregnancy Register. The control group consisted of children identified from the Child Health System database across Northern Ireland. Data were gathered on covariates recognised as influencing child development.
Main outcome measures Neurodevelopment assessed using either the Bayley Scales of Infant Development or the Griffiths Mental Development Scales.
Results 210 children underwent assessment by a single researcher blinded to antiepileptic drug exposure. 23 (39.6%) children exposed in utero to NaV, 10 (20.4%) exposed to CBZ and one (2.9%) exposed to LTG had evidence of mild or significant developmental delay, compared to two (4.5%) children in the control group. Multivariable analysis demonstrated that in utero exposure to NaV (OR 26.1, 95% CI 4.9 to 139; p<0.001) and to CBZ (OR 7.7, 95% CI 1.4 to 43.1; p<0.01) but not to LTG had a significant detrimental effect on neurodevelopment.
Conclusion In utero exposure to LTG did not have the detrimental effect on child development that was seen with NaV and with CBZ.
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Funding This study was funded by a fellowship from the Irish Institute of Neurology and Neurosurgery and a fellowship from the Royal Belfast Hospital for Sick Children. Neither source of funding had any involvement in the study design, data collection, analysis and interpretation, or in the writing and submission of this report.
Competing interests The UK Epilepsy and Pregnancy Register was made possible by a research grant from the Epilepsy Research Foundation and a number of unrestricted educational grants from pharmaceutical companies (Glaxo-Smith-Kline, Sanofi-Aventis, UCB-Pharma, Janssen-Cilag, Novartis, Pfizer and Eisai). Over the lifetime of the register, these grants have exceeded £10 000 from each company/grant awarding body. An internet-based website detailing the aims of the UK Epilepsy and Pregnancy Register was made possible by a grant from Glaxo-Smith-Kline and UCB-Pharma. JM has attended meetings with the support of various pharmaceutical companies, and has given lectures at the behest of pharmaceutical companies, for which he has received honoraria.
Ethics approval This study was conducted with the approval of the Research Ethics Committee, Queens University, Belfast (REC file number 322/01).
Provenance and peer review Not commissioned; externally peer reviewed.
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