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Published online before print August 13, 2008, doi:10.1212/01.wnl.0000316199.92256.af)
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NEUROLOGY 2008;71:1109-1117
© 2008 American Academy of Neurology


Views and Reviews

Pregnancy registries in epilepsy

A consensus statement on health outcomes

K. J. Meador, MD, P. B. Pennell, MD, C. L. Harden, MD, J. C. Gordon, PhD, T. Tomson, MD, PhD, P. W. Kaplan, MB, FRCP, G. L. Holmes, MD, J. A. French, MD, W. A. Hauser, MD, P. G. Wells, PhD, J. A. Cramer, BS For the HOPE Work Group*

From the Department of Neurology (K.J.M.), University of Florida, Gainesville; Emory Epilepsy Program (P.B.P.), Emory University School of Medicine, Atlanta, GA; Department of Neurology (C.L.H.), Weill Cornell Medical College, New York, NY; Epilepsy Therapy Project (J.C.G.), Reston, VA; Department of Clinical Neuroscience (T.T.), Karolinska Institutet, Stockholm, Sweden; Johns Hopkins University School of Medicine (P.W.K.), Baltimore, MD; Neuroscience Center at Dartmouth (G.L.H.), Dartmouth Medical School, Lebanon, NH; New York University (J.A.F.), New York; Columbia University College of Physicians and Surgeons (W.A.H.), New York, NY; University of Toronto (P.G.W.), Ontario, Canada; and Department of Psychiatry (J.A.C.), Yale University School of Medicine, New Haven, CT.

Address correspondence and reprint requests to Dr. Kimford J. Meador, Department of Neurology, Emory University, Woodruff Memorial Research Building, 101 Woodruff Circle, Suite 6000, Atlanta, GA 30322 Kimford.meador{at}emory.edu.

Most pregnant women with epilepsy require antiepileptic drug (AED) therapy. Present guidelines recommend optimizing treatment prior to conception, choosing the most effective AED for seizure type and syndrome, using monotherapy and lowest effective dose, and supplementing with folate. The Epilepsy Therapy Project established the international Health Outcomes in Pregnancy and Epilepsy (HOPE) forum to learn more about the impact of AEDs on the developing fetus, particularly the role of pregnancy registries in studying AED teratogenicity. The primary outcome of interest in these registries is the occurrence of major congenital malformations, with some data collected on minor malformations. Cognitive and behavioral outcomes are often beyond the timeframe for follow-up of these registries and require independent study. The HOPE consensus report describes the current state of knowledge and the limitations to interpretations of information from the various sources. Data regarding specific risks for both older and newer AEDs need to be analyzed carefully, considering study designs and confounding factors. There is a critical need for investigations to delineate the underlying mechanisms and explain the variance seen in outcomes across AEDs and within a single AED.

Abbreviations: AED = antiepileptic drug; EURAP = European and International Registry of Antiepileptic Drugs in Pregnancy; FDA = Food and Drug Administration; HOPE = Health Outcomes in Pregnancy and Epilepsy; NEAD = Neurodevelopmental Effects of Antiepileptic Drugs; WWE = women with epilepsy.


Supplemental data at www.neurology.org

e-Pub ahead of print on August 13, 2008, at www.neurology.org.

*Members of the HOPE Work Group are listed in the appendix.

This work was funded by the Epilepsy Therapy Project, a nonprofit organization.

Disclosure: Author disclosures are provided at the end of the article.

Received June 29, 2007. Accepted in final form March 19, 2008.




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