DRUG PREGNANCY REGISTRIES Jan Cragan, M.D.

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DRUG PREGNANCY REGISTRIESJan Cragan, M.D.

• 1-800-336-2176 Antiretroviral Pregnancy
  Registry Lamotrigine Pregnancy Registry
  Sumatriptan Pregnancy Registry Bupropion
  Pregnancy Registry
• 1-888-233-2334
• Antiepileptic Drug (AED) Pregnancy Registry
• 1-800-986-8999 Pregnancy Registry for
  VARIVAX

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DRUG PREGNANCY REGISTRIESStrengths

• Shift in industry focus toward actively
  monitoring for adverse effects of drug use in
  pregnancy
• Prospective ascertainment reduces selection bias
  and allows calculation of the risk of adverse
  outcomes
• Increased statistical power to identify defects
  resulting from individual drug exposures

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DRUG PREGNANCY REGISTRIESLimitations

• Difficulty in obtaining sufficient sample size to
  evaluate changes in individual defect rates
• Lack of a control group
• Quality of exposure and outcome data
• Confidentiality issues

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CONSIDERATIONS FOR DEVELOPMENTOF A CENTRAL
PREGNANCY REGISTRY

• Definition of a central registry
• Data to be collected
• Administration and funding
• Is a central registry worth the effort?