Using observational cohort data for studying drug effects on pregnancy outcome-Methodological considerations

Reproductive Toxicology

Volumn 26, Issue 1, 2008, Pages 36-41

  Schaefer, Christof ^a   Ornoy, Asher ^b   Clementi, Maurizio ^c   Meister, Reinhard ^d   Weber Schoendorfer, Corinna ^a  

^a Berlin Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy   (Germany)

^b HEBREW UNIVERSITY OF JERUSALEM   (Israel)

^c Dipartimento di Pediatria   (Italy)

^d BEUTH UNIVERSITY OF APPLIED SCIENCES   (Germany)

Author keywords

Abnormalities, Drug induced; Epidemiology; Human; Observational studies; Pregnancy; Pregnancy outcome; Risk assessment; Teratology information service

Indexed keywords

HEPARIN; NADROPARIN; WARFARIN;

ARTICLE; BIRTH DEFECT; CHECKLIST; COHORT ANALYSIS; DIAGNOSTIC PROCEDURE; DISEASE ASSOCIATION; DISEASE CLASSIFICATION; DRUG EFFECT; DRUG SUBSTITUTION; DRUG WITHDRAWAL; EMBRYO DEVELOPMENT; FOLLOW UP; INFORMATION SERVICE; LUNG EMBOLISM; METHODOLOGY; MULTICENTER STUDY; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; PREGNANCY OUTCOME; PREGNANT WOMAN; PRENATAL DRUG EXPOSURE; REPRODUCIBILITY; RISK ASSESSMENT; SPONTANEOUS ABORTION; SYSTEMATIC ERROR; TERATOGENICITY; TERATOLOGY;

ABNORMALITIES, DRUG-INDUCED; ADULT; CASE-CONTROL STUDIES; COHORT STUDIES; DRUG INFORMATION SERVICES; EPIDEMIOLOGIC RESEARCH DESIGN; FEMALE; HUMANS; OBSERVATION; PHARMACEUTICAL PREPARATIONS; PREGNANCY; PREGNANCY OUTCOME; TERATOLOGY;

EID: 48349134531     PISSN: 08906238     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.reprotox.2008.05.064     Document Type: Article

References (28)

1. Clementi M., Di Gianantonio E., and Ornoy A. Teratology information services in Europe and their contribution to the prevention of congenital anomalies. Commun Genet 5 (2002) 8-12
2. Eléfant E., Boyer M., Boyer P., Galliot B., and Roux C. Teratogenic agent information centre: fifteen years of counseling and pregnancy follow-up. Teratology 46 (1992) 35-44
3. Garbis J.M., Robert E., and Peters P.W.J. Experience of two teratology information services in Europe. Teratology 42 (1990) 629-634
4. Schaefer C., Hannemann D., and Meister R. Post-marketing surveillance system for drugs in pregnancy-15 years experience of ENTIS. Reprod Toxicol 20 (2005) 331-343
5. Hancock R.L., Koren G., Einarson A., and Ungar W.J. The effectiveness of Teratology Information Services (TIS). Reprod Toxicol 23 (2007) 125-132
6. Avorn J. In defense of pharmacoepidemiology-embracing the Yin and Yang of drug research. NEJM 357 (2007) 2219-2221
7. von Elm E., Altman D.G., Egger M., Pocock S.J., Gøtzsche P.C., Vandenbroucke J.P., et al. The strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. PLoS Med 4 (2007) 1623-1627
8. von Elm E., Altman D.G., Egger M., Pocock S.J., Gøtzsche P.C., Vandenbroucke J.P., et al. Strengthening the reporting of observational studies in epidemiology (STROBE): explanation and elaboration. PLoS Med 4 (2007) 1628-1654
9. Jones K.L., Johnson D.L., and Chambers C.D. Monitoring leflunomide (Arava) as a new potential teratogen. Teratology 65 (2002) 200-202
10. Rasmussen S.A., Olney R.S., Holmes L.B., Lin A.E., Keppler-Noreuil K.M., and Moore C.A. National birth defects prevention study. Guidelines for case classification for the national birth defects prevention study. Birth Defects Res (A) 67 (2003) 193-201
11. Holmes L.B. Need for inclusion and exclusion criteria for the structural abnormalities recorded in children born from exposed pregnancies. Teratology 64 (1999) 79-82
12. Einarson A., Ahmed F., Gallo M., Einarson T.R., and Koren G. Reproducibility of medical information obtained via the telephone vs personal interview. Vet Human Toxicol 41 (1999) 397-400
13. Gur C., Diav-Citrin O., Shechtman S., Arnon J., and Ornoy A. Pregnancy outcome after first trimester exposure to corticosteroids: a prospective controlled study. Reprod Toxicol 18 (2004) 93-101
14. Diav-Citrin O., Shechtman S., Ornoy S., Arnon J., Schaefer C., Garbis H., et al. The safety of haloperidol and penfluridol in pregnancy. A multicenter study. Clin Psychiatry 66 (2005) 317-322
15. Meister R., and Schaefer C. Statistical methods for estimating the probability of spontaneous abortion in observational studies-analyzing pregnancies exposed to coumarin derivatives. Reprod Toxicol 26 (2008) 31-35
16. Hosmer D.W., and Lemeshow S. Applied logistic regression (2000), Wiley, New York
17. Draper N.R., and Smith H. Applied regression analysis (1998), Wiley, New York
18. Schaefer C., Hannemann D., Meister R., Eléfant E., Paulus W., Vial T., et al. Vitamin K antagonists and pregnancy outcome. A multi-centre prospective study. Thromb Haemost 95 (2006) 949-957
19. Agresti A. Categorical data analysis. 2nd edition (2002), Wiley, New York
20. Johnson K.A., Weber P.A., Jones K.L., and Chambers C.D. Selection bias in teratology information service pregnancy outcome studies. Teratology 64 (2001) 79-82
21. Villalbí J.R., Salvador J., Cano-Serral G., Rodríguez-Sanz M.C., and Borrell C. Maternal smoking, social class and outcomes of pregnancy. Paediatr Perinat Epidemiol 21 (2007) 441-447
22. David M., Pachaly J., and Vetter K. Perinatal outcome in Berlin (Germany) among immigrants from Turkey. Arch Gynecol Obstet 274 (2006) 271-278
23. Rodriguez-Escudero F.J. The economic implication in pregnancy outcome. Int J Gynaecol Obstet 19 (1981) 231-237
24. Raatikainen K., Heiskanen N., and Heinonen S. Under-attending free antenatal care is associated with adverse pregnancy outcomes. BMC Public Health 7 (2007) 268
25. Savitz D.A., Kaufman J.S., Dole N., Siega-Riz A.M., Thorp Jr. J.M., and Kaczor D.T. Poverty, education, race, and pregnancy outcome. Ethn Dis 14 (2004) 322-329
26. Martinez-Frias M.L., and Rodriguez-Pinilla E. The problems of using data from teratology information services (TIS) to identify putative teratogens. Teratology 60 (1999) 54-55
27. Ornoy A., and Mastroiacovo P. More on data from Teratogen Information Systems (TIS). Teratology 61 (2000) 327-328
28. Felix R.J., Jones K.L., Johnson K.A., McCloskey C.A., Chambers C.D., and Organization of Teratology Information Services Collaborative Research Group. Postmarketing surveillance for drug safety in pregnancy: the organization of teratology information services project. Birth Defects Res A 70 (2004) 944-947