A population based case-control teratologic study of oral metronidazole treatment during pregnancy

Research output: Contribution to journalArticle

114 Citations (Scopus)

Abstract

Objective: To study human teratogenic risk of metronidazole. Design: A case-control analysis of congenital abnormalities after oral metronidazole treatment during pregnancy grouped by months of gestation. The source of information concerning the use of drugs during pregnancy was the prospective data of the women's prenatal logbook and the retrospective data of a questionnaire filled in by mothers. Setting: The large population-based dataset of the Hungarian Case-Control Surveillance of Congenital Abnormalities, 1980-1991. Participants: The control group involved 30,663 pregnant women who had healthy babies; the response rate was 65% . The index group consisted of 17,300 pregnant women who had offspring with congenital abnormalities from the study pregnancy; data were available for 82% of these women. Results: Of 30,663 pregnant women in the control group, 1041 (3.4%) were treated with metronidazole, 162 (0.53%) in the second to third month of gestation. Of 17,300 pregnant women in the index group, 665 (3·8%) were treated with metronidazole, 104 (0·66%) in the second to third months. McNemar analysis for case-matched control pairs indicated a somewhat higher maternal metronidazole treatment in the second-third months of gestation in nine cases with cleft lip with or without cleft palate, but it was not possible to exclude the recall bias. In addition, this finding was not confirmed by the comparison of cases with cleft lip with or without cleft palate and the total control group. Conclusion: Treatment with oral metronidazole during pregnancy presents no clinically important association with congenital abnormalities.

Original languageEnglish
Pages (from-to)322-327
Number of pages6
JournalBritish Journal of Obstetrics and Gynaecology
Volume105
Issue number3
Publication statusPublished - 1998

Fingerprint

Metronidazole
Case-Control Studies
Pregnancy
Pregnant Women
Population
Cleft Lip
Cleft Palate
Control Groups
Therapeutics
Mothers
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Obstetrics and Gynaecology

Cite this

@article{9966b9300dd74322afa2edda29faac97,
title = "A population based case-control teratologic study of oral metronidazole treatment during pregnancy",
abstract = "Objective: To study human teratogenic risk of metronidazole. Design: A case-control analysis of congenital abnormalities after oral metronidazole treatment during pregnancy grouped by months of gestation. The source of information concerning the use of drugs during pregnancy was the prospective data of the women's prenatal logbook and the retrospective data of a questionnaire filled in by mothers. Setting: The large population-based dataset of the Hungarian Case-Control Surveillance of Congenital Abnormalities, 1980-1991. Participants: The control group involved 30,663 pregnant women who had healthy babies; the response rate was 65{\%} . The index group consisted of 17,300 pregnant women who had offspring with congenital abnormalities from the study pregnancy; data were available for 82{\%} of these women. Results: Of 30,663 pregnant women in the control group, 1041 (3.4{\%}) were treated with metronidazole, 162 (0.53{\%}) in the second to third month of gestation. Of 17,300 pregnant women in the index group, 665 (3·8{\%}) were treated with metronidazole, 104 (0·66{\%}) in the second to third months. McNemar analysis for case-matched control pairs indicated a somewhat higher maternal metronidazole treatment in the second-third months of gestation in nine cases with cleft lip with or without cleft palate, but it was not possible to exclude the recall bias. In addition, this finding was not confirmed by the comparison of cases with cleft lip with or without cleft palate and the total control group. Conclusion: Treatment with oral metronidazole during pregnancy presents no clinically important association with congenital abnormalities.",
author = "E. Czeizel and M. Rockenbauer",
year = "1998",
language = "English",
volume = "105",
pages = "322--327",
journal = "BJOG: An International Journal of Obstetrics and Gynaecology",
issn = "1470-0328",
publisher = "Wiley-Blackwell",
number = "3",

}

TY - JOUR

T1 - A population based case-control teratologic study of oral metronidazole treatment during pregnancy

AU - Czeizel, E.

AU - Rockenbauer, M.

PY - 1998

Y1 - 1998

N2 - Objective: To study human teratogenic risk of metronidazole. Design: A case-control analysis of congenital abnormalities after oral metronidazole treatment during pregnancy grouped by months of gestation. The source of information concerning the use of drugs during pregnancy was the prospective data of the women's prenatal logbook and the retrospective data of a questionnaire filled in by mothers. Setting: The large population-based dataset of the Hungarian Case-Control Surveillance of Congenital Abnormalities, 1980-1991. Participants: The control group involved 30,663 pregnant women who had healthy babies; the response rate was 65% . The index group consisted of 17,300 pregnant women who had offspring with congenital abnormalities from the study pregnancy; data were available for 82% of these women. Results: Of 30,663 pregnant women in the control group, 1041 (3.4%) were treated with metronidazole, 162 (0.53%) in the second to third month of gestation. Of 17,300 pregnant women in the index group, 665 (3·8%) were treated with metronidazole, 104 (0·66%) in the second to third months. McNemar analysis for case-matched control pairs indicated a somewhat higher maternal metronidazole treatment in the second-third months of gestation in nine cases with cleft lip with or without cleft palate, but it was not possible to exclude the recall bias. In addition, this finding was not confirmed by the comparison of cases with cleft lip with or without cleft palate and the total control group. Conclusion: Treatment with oral metronidazole during pregnancy presents no clinically important association with congenital abnormalities.

AB - Objective: To study human teratogenic risk of metronidazole. Design: A case-control analysis of congenital abnormalities after oral metronidazole treatment during pregnancy grouped by months of gestation. The source of information concerning the use of drugs during pregnancy was the prospective data of the women's prenatal logbook and the retrospective data of a questionnaire filled in by mothers. Setting: The large population-based dataset of the Hungarian Case-Control Surveillance of Congenital Abnormalities, 1980-1991. Participants: The control group involved 30,663 pregnant women who had healthy babies; the response rate was 65% . The index group consisted of 17,300 pregnant women who had offspring with congenital abnormalities from the study pregnancy; data were available for 82% of these women. Results: Of 30,663 pregnant women in the control group, 1041 (3.4%) were treated with metronidazole, 162 (0.53%) in the second to third month of gestation. Of 17,300 pregnant women in the index group, 665 (3·8%) were treated with metronidazole, 104 (0·66%) in the second to third months. McNemar analysis for case-matched control pairs indicated a somewhat higher maternal metronidazole treatment in the second-third months of gestation in nine cases with cleft lip with or without cleft palate, but it was not possible to exclude the recall bias. In addition, this finding was not confirmed by the comparison of cases with cleft lip with or without cleft palate and the total control group. Conclusion: Treatment with oral metronidazole during pregnancy presents no clinically important association with congenital abnormalities.

UR - http://www.scopus.com/inward/record.url?scp=0031938752&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0031938752&partnerID=8YFLogxK

M3 - Article

C2 - 9532994

AN - SCOPUS:0031938752

VL - 105

SP - 322

EP - 327

JO - BJOG: An International Journal of Obstetrics and Gynaecology

JF - BJOG: An International Journal of Obstetrics and Gynaecology

SN - 1470-0328

IS - 3

ER -