Understanding Pregnancy Registries

Pregnancy Registries

A pregnancy registry is a surveillance study that enrolls pregnant women who have been taking a specific medicine.¹ The babies born to these women are compared with those born to women who are not taking the same medication. In this way, pregnancy registries play a key role in the post-marketing surveillance of drugs by supplying data regarding the effects of specific drugs on the development of babies. Evaluation of a large number of pregnancies is needed for these studies to be statistically significant, which is why all women are encouraged to enroll in an appropriate registry as soon as they discover they are pregnant. In general, the information collected through each woman’s participation in a registry, as well as the fact that she participated, is kept confidential.¹

Antiepileptic Drug Pregnancy Registries

Currently, there are five major pregnancy registries focused specifically on the study of pregnant women taking antiepileptic drugs (AEDs). AEDs are used to control seizures in people with epilepsy, and are commonly prescribed for the treatment of non-epileptic neurological pain symptoms such as migraines and tremor, and for psychiatric disorders such as mood and bipolar disorders.

• Australian Pregnancy Registry of Women on Antiepileptic Drugs: The Australian Registry, established in 1999, enrolls women with epilepsy treated with AEDs, untreated women with epilepsy and those taking AEDs for other indications.² Data from patients fulfilling the criteria for enrollment also are supplied to the European registry (EURAP) database. To date, 830 women have contacted the registry, 630 have been enrolled, and 565 pregnancies reached completion, including 10 sets of twins.²

  The Australian registry receives support from The Epilepsy Society of Australia, GlaxoSmithKline, Janssen-Cilag, Novartis, Pfizer, Sanofi Synthelabo, and UCB Pharma.

• European Registry of Antiepileptic Drugs and Pregnancy (EURAP): Established in 1999, EURAP is a prospective registry set up originally in Europe and later extended to several other countries in Asia, Oceania, and South America.³ The primary objective of the EURAP core protocol is to determine the comparative risk of major fetal malformations after intake of AEDs during pregnancy.³ Information on drug therapy and a large set of potential risk factors is obtained. Follow-up data are collected prospectively online once each trimester, at birth and one year after delivery.³ More than 300 physicians from 37 countries have contributed cases to the central registry.³ As of June 2004, more than 5,000 pregnancies had been included in the central database.³

  The EURAP registry receives support from GlaxoSmithKline, Janssen-Cilag, Novartis, Pfizer, Sanofi Synthelabo, and UCB Pharma.

• International Lamotrigine Pregnancy Registry: This registry forms part of an epidemiologic safety program monitoring pregnancy outcomes in women who have been exposed to lamotrigine.⁴ Established in 1992, this primarily prospective observational study aims to assess the risk of all major malformations associated with first trimester exposure to lamotrigine monotherapy.⁴ Data on lamotrigine polytherapy and patterns of specific malformation types are reviewed as well.⁴ Physicians from around the world, in 31 countries, report on women’s exposure to lamotrigine during pregnancy and subsequent outcomes to the registry on a voluntary basis.⁴ The risk of major congenital malformations following lamotrigine monotherapy exposure appears to be similar to that in the general population, though the sample size is insufficient to allow definitive conclusions at this time.⁴

  The Lamotrigine registry receives support from by GlaxoSmithKline.

• North American Antiepileptic Drug Pregnancy Registry: Established in 1997, this registry is designed for pregnant women in the United States and Canada.⁵ The major objective was to obtain, as quickly as possible, information on the frequency of major malformations among infants whose mothers had taken one or more anticonvulsant drugs to prevent seizures or to treat any other medical condition.⁵ The highest priority was to gather new information on the many “new” anticonvulsant drugs marketed in the past 10 years.⁵ As of July 12, 2004, total enrollment was 3,708 women.⁵

  The North American registry receives support from Abbott, Eisai, GlaxoSmithKline, Ortho-McNeil, Novartis, and Pfizer.

• UK Epilepsy and Pregnancy Register and UK Epilepsy & Pregnancy Group: Established in 1996, the UK Epilepsy and Pregnancy Register is a prospective, observational registration and follow up study created by Dr J.I. Morrow in response to uncertainty regarding the relative safety in pregnancy of recently licensed AEDs.⁶ Women who register need not be taking anticonvulsant medication at that time.⁷ As of August 2004, almost 4,000 women from throughout the UK have been registered prospectively.⁷ This program also includes follow-up studies of child development and collaboration with the international pregnancy registry study ⁷

  The UK registry receives support from Epilepsy Research Foundation, GlaxoSmithKline, Janssen-Cilag, Parke-Davis, Sanofi Synthelabo, Parke-Davis, and UCB Pharma.

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  1 "Guide to Pregnancy Registries," Food and Drug Administration (FDA): Office of Women's Health, FDA, 2 Dec. 2004.

  2 Vajda, Frank; Lander, Cecilie; and O'Brien, Terrence. "Australian Pregnancy Registry of Women on Antiepileptic Drugs." Epilepsia 2004;45(11):1466.

  3 Tomson, Torbjorn; Battino, Dina; and Bonizzoni, Eminio. "EURAP: An International Registry of Antiepileptic Drugs and Pregnancy." Epilepsia, 2004;45(11):1463-1464.

  4 Cunnington, Marianne. "The International Lamotrigine Pregnancy Registry Update for the Epilepsy Foundation." Epilepsia 2004;45(11):1468.

  5 Holmes, Lewis and Wyszynski, Deigo. "North American Antiepileptic Drug Pregnancy Registry." Epilepsia 2004;45(11):1465.

  6 Craig JJ and Morrow JI. "New antiepileptic drugs. Register of women who take the drugs during pregnancy has been set up." BMJ 1997; 314:603.

  7 Russell, Aline; Craig, John; and Morrison, Patrick. "U.K. Epilepsy and Pregnancy Group." Epilepsia 2004;45(11):1467.