Chapter 17 Pregnancy Registries. Strengths, Weaknesses, and Bias Interpretation of Pregnancy Registry Data

International Review of Neurobiology

Volumn 83, Issue , 2008, Pages 283-304

  Cunnington, Marianne ^a   Messenheimer, John ^b  

^a GLAXOSMITHKLINE   (United Kingdom)

^b GLAXOSMITHKLINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTICONVULSIVE AGENT;

CONGENITAL MALFORMATION; DRUG MONITORING; EPIDEMIOLOGY; EPILEPSY; FEMALE; HUMAN; PREGNANCY; PREGNANCY COMPLICATION; REGISTER; REVIEW;

ABNORMALITIES, DRUG-INDUCED; ANTICONVULSANTS; BIAS (EPIDEMIOLOGY); DRUG MONITORING; EPILEPSY; FEMALE; HUMANS; PREGNANCY; PREGNANCY COMPLICATIONS; REGISTRIES;

EID: 53049099424     PISSN: 00747742     EISSN: None     Source Type: Book Series    
DOI: 10.1016/S0074-7742(08)00017-2     Document Type: Review

References (24)

1. CIOMS. Report of the CIOMS Working Group VI. Management of safety information from clinical trials (2005) ISBN 92 9036 079 8
2. Committee for Medicinal Products for Human Use (CHMP). Guideline on exposure to medicinal products during pregnancy: Need for post-authorisation data (2005). http://www.emea.europa.eu/pdfs/human/phvwp/31366605en.pdf EMEA/CHMP/313666/2005
3. Correa A., Cragan J.D., Kucik J.E., Alverson C.J., Gilboa S.M., Balakrishnan R., Strickland M.J., Duke C.W., O'Leary L.A., Riehle-Colarusso T., Siffal C., Gambrell D., et al. MACDP: 40th Anniversary Special Edition Surveillance Report. Birth Defects Res. A Clin. Mol. Teratol. 79 2 (2007) 1-177
4. Covington D., Tilson H., and Elder J. Assessing teratogenicity of antiretroviral drugs: Monitoring and analysis plan of the antiretroviral pregnancy registry. Pharmacoepidemiol. Drug Saf. 13 (2004) 537-545
5. Cunnington M., and Tennis P. International Lamotrigine Pregnancy Registry Scientific Advisory Committee. Lamotrigine and the risk of malformations in pregnancy. Neurology 64 (2005) 955-960
6. Czeizel A.E. First 25 years of the Hungarian Congenital Abnormalities Register. Teratology 55 (1997) 299-305
7. Fleiss J.L., Levin B., and Paik M.C. Statistical Methods for Rates and Proportions. 3rd ed. (2003), John Wiley and Sons, New York
8. Hanson J.W., Myrianthopoulos N.C., Harvey M.A., and Smith D.W. Risks to the offspring of women treated with hydantoin anticonvulsants with emphasis on fetal hydantoin syndrome. J. Paediatr. 89 (1976) 662-668
9. Holmes L.B., Wyszynski D.F., and Lieberman E. The AED (Antiepileptic Drug) pregnancy registry. A 6-year experience. Arch. Neurol. 61 (2004) 673-678
10. Machin D., Campbell M., Fayers P., and Pinol A. Sample Size Tables for Clinical Studies. 2nd ed. (1997), Blackwell Science, Madden, MA
11. Magnus L. The Keppra (levetiracetam) Pregnancy Registry. Presented 58th Annual Meeting of the American Epilepsy Society (2004)
12. Metropolitan Atlanta Congenital Defects Program. Surveillance Procedure Manual and Guide to Computerized Anomaly Record (1998), Centers for Disease Control, Atlanta, GA
13. Mitchell A. Systematic identification of drugs that cause birth defects - a new opportunity. N. Eng. J. Med. 349 (2003) 2556-2559
14. Mitchell A., Rosenberg L., Shapiro S., and Slone D. Birth defects related to Bendectin use in pregnancy. Oral clefts and cardiac defects. JAMA 245 (1981) 2311-2314
15. Morrow J.I., Russell A., Gutherie E., et al. Malformation risks of antiepileptic drugs in pregnancy: A prospective study from the UK Epilepsy and Pregnancy Register. J. Neurol. Neurosurg. Psychiatry 77 (2006) 193-198
16. Nelson K., and Holmes L.B. Malformations due to presumed spontaneous mutations in newborn infants. N. Eng. J. Med. 320 (1989) 19-23
17. Newcombe R. Two-sided confidence intervals for the single proportion: Comparison of seven methods. Stat. Med. 17 (1998) 857-872
18. Russell A.J.C., Craig J.J., Morrison P., Irwin B., Waddell R., Parsons L., et al. UK epilepsy and pregnancy group. Epilepsia 45 (2004) 1467
19. Tomson T., Battino D., Bonizzoni E., et al. EURAP: An international registry of antiepileptic drugs and pregnancy. Epilepsia 45 (2004) 1463-1464
20. US Department of Health and Human Sciences Food and Drug Administration. Guidance for Industry. Establishing Pregnancy Exposure Registries (2002)
21. US Department of Health and Human Sciences Food and Drug Administration. Reviewer Guidance. Evaluating the risks of drug exposure in human pregnancies (2005)
22. Wide K., Winbladh B., and Kallen B. Major malformations in infants exposed to anti-epileptic drugs in utero with emphasis on carbamazepine and valproic acid: A nation-wide, population based register study. Acta Paediatr. 93 (2004) 174-176
23. Wyszynski D.F., Nambisan M., Surve T., et al. Increased rate of major malformations in offspring exposed to valproate during pregnancy. Neurology 64 (2005) 961-965
24. Yoon P., Ramussen S.A., and Lynberg M. The National Birth Defects Prevention Study. Public Health Rep. 116 S1 (2001) 32-40