A hüvelyi metronidazolkezelés lehetséges teratogenitása, valamint hatása a terhességi korra és a koraszülés gyakoriságára - Eset-kontroll tanulmány

Translated title of the contribution: Possible teratogenicity of vaginal metronidazole treatment and its effect on gestational age and prevalence of preterm birth - Case-control study

Zoltán Kazy, E. Puhó, E. Czeizel

Research output: Contribution to journalArticle

Abstract

INTRODUCTION - The primary aim of the study was to investigate the possibility of a teratogenic effect of vaginal metronidazole treatment during pregnancy. MATERIALS AND METHODS - Various congenital abnormalities and all (1-3) their matched controls were analysed in the population-based database of the Hungarian Case-Control Surveillance of Congenital Abnormalities between 1980 and 1996. The study group comprised 38151 pregnant women who had newborns without any congenital abnormalities (control group) and 22 843 pregnant women who had newborns or fetuses with congenital abnormalities. Main outcome measures were analysed in 22 congenital abnormalities groups. The use of metronidazole during the second and third trimesters being common, the secondary objective of the study was to analyse the effect of vaginal metronidazole treatment (500 mg of Klion) on gestational age and birth weight in the control group without congenital abnormalities. RESULTS - The prevalence of vaginal metronidazole treatment during pregnancy was 1.7% in the case group (n=388) and 1.5% in the control group (n=570) (odds ratio (OR), 1.1, 95% confidence interval (CI): 1.0-1.3). Comparisons of cases and their matched controls showed an association between vaginal metronidazole treatment during the second and third months of gestation and congenital hydrocephaly (adjusted OR with 95% CI, 10.7, 1.1-104.5), but this was only based on five cases. The analysis of metronidazole treatment reported by the physicians did not confirm this association. After metronidazole use the mean gestational age was slightly shorter (by 0.1 week) and the mean birth weight was also slightly lower (by 40g) in the treated group. CONCLUSION - This finding should only be regarded as an indication for a possible association between vaginal treatment with metronidazole during pregnancy and congenital hydrocephalus. The results showed that vaginal metronidazole treatment alone was not able to prevent a possible vaginal infection that is associated with preterm birth, and that the prevalence of low birth weight was higher among treated women. The protective effect of metronidazole on preterm birth and low birth weight was not confirmed.

Original languageHungarian
Pages (from-to)643-648
Number of pages6
JournalLege Artis Medicinae
Volume16
Issue number7
Publication statusPublished - Jul 2006

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Metronidazole
Premature Birth
Contraception
Gestational Age
Case-Control Studies
Therapeutics
Pregnancy
Low Birth Weight Infant
Hydrocephalus
Birth Weight
Control Groups
Pregnant Women
Odds Ratio
Newborn Infant
Confidence Intervals
Third Pregnancy Trimester
Second Pregnancy Trimester
Fetus
Outcome Assessment (Health Care)
Databases

ASJC Scopus subject areas

  • Medicine(all)

Cite this

@article{e8fc45afdb1343fd8510c2b38c620146,
title = "A h{\"u}velyi metronidazolkezel{\'e}s lehets{\'e}ges teratogenit{\'a}sa, valamint hat{\'a}sa a terhess{\'e}gi korra {\'e}s a korasz{\"u}l{\'e}s gyakoris{\'a}g{\'a}ra - Eset-kontroll tanulm{\'a}ny",
abstract = "INTRODUCTION - The primary aim of the study was to investigate the possibility of a teratogenic effect of vaginal metronidazole treatment during pregnancy. MATERIALS AND METHODS - Various congenital abnormalities and all (1-3) their matched controls were analysed in the population-based database of the Hungarian Case-Control Surveillance of Congenital Abnormalities between 1980 and 1996. The study group comprised 38151 pregnant women who had newborns without any congenital abnormalities (control group) and 22 843 pregnant women who had newborns or fetuses with congenital abnormalities. Main outcome measures were analysed in 22 congenital abnormalities groups. The use of metronidazole during the second and third trimesters being common, the secondary objective of the study was to analyse the effect of vaginal metronidazole treatment (500 mg of Klion) on gestational age and birth weight in the control group without congenital abnormalities. RESULTS - The prevalence of vaginal metronidazole treatment during pregnancy was 1.7{\%} in the case group (n=388) and 1.5{\%} in the control group (n=570) (odds ratio (OR), 1.1, 95{\%} confidence interval (CI): 1.0-1.3). Comparisons of cases and their matched controls showed an association between vaginal metronidazole treatment during the second and third months of gestation and congenital hydrocephaly (adjusted OR with 95{\%} CI, 10.7, 1.1-104.5), but this was only based on five cases. The analysis of metronidazole treatment reported by the physicians did not confirm this association. After metronidazole use the mean gestational age was slightly shorter (by 0.1 week) and the mean birth weight was also slightly lower (by 40g) in the treated group. CONCLUSION - This finding should only be regarded as an indication for a possible association between vaginal treatment with metronidazole during pregnancy and congenital hydrocephalus. The results showed that vaginal metronidazole treatment alone was not able to prevent a possible vaginal infection that is associated with preterm birth, and that the prevalence of low birth weight was higher among treated women. The protective effect of metronidazole on preterm birth and low birth weight was not confirmed.",
keywords = "Birth weight, Case-control study, Congenital abnormalities, Congenital hydrocephaly, Gestational age, Low birth weight, Metronidazole, Preterm birth, Vaginal administration",
author = "Zolt{\'a}n Kazy and E. Puh{\'o} and E. Czeizel",
year = "2006",
month = "7",
language = "Hungarian",
volume = "16",
pages = "643--648",
journal = "Lege Artis Medicinae",
issn = "0866-4811",
publisher = "Literatura Medica Publishing House",
number = "7",

}

TY - JOUR

T1 - A hüvelyi metronidazolkezelés lehetséges teratogenitása, valamint hatása a terhességi korra és a koraszülés gyakoriságára - Eset-kontroll tanulmány

AU - Kazy, Zoltán

AU - Puhó, E.

AU - Czeizel, E.

PY - 2006/7

Y1 - 2006/7

N2 - INTRODUCTION - The primary aim of the study was to investigate the possibility of a teratogenic effect of vaginal metronidazole treatment during pregnancy. MATERIALS AND METHODS - Various congenital abnormalities and all (1-3) their matched controls were analysed in the population-based database of the Hungarian Case-Control Surveillance of Congenital Abnormalities between 1980 and 1996. The study group comprised 38151 pregnant women who had newborns without any congenital abnormalities (control group) and 22 843 pregnant women who had newborns or fetuses with congenital abnormalities. Main outcome measures were analysed in 22 congenital abnormalities groups. The use of metronidazole during the second and third trimesters being common, the secondary objective of the study was to analyse the effect of vaginal metronidazole treatment (500 mg of Klion) on gestational age and birth weight in the control group without congenital abnormalities. RESULTS - The prevalence of vaginal metronidazole treatment during pregnancy was 1.7% in the case group (n=388) and 1.5% in the control group (n=570) (odds ratio (OR), 1.1, 95% confidence interval (CI): 1.0-1.3). Comparisons of cases and their matched controls showed an association between vaginal metronidazole treatment during the second and third months of gestation and congenital hydrocephaly (adjusted OR with 95% CI, 10.7, 1.1-104.5), but this was only based on five cases. The analysis of metronidazole treatment reported by the physicians did not confirm this association. After metronidazole use the mean gestational age was slightly shorter (by 0.1 week) and the mean birth weight was also slightly lower (by 40g) in the treated group. CONCLUSION - This finding should only be regarded as an indication for a possible association between vaginal treatment with metronidazole during pregnancy and congenital hydrocephalus. The results showed that vaginal metronidazole treatment alone was not able to prevent a possible vaginal infection that is associated with preterm birth, and that the prevalence of low birth weight was higher among treated women. The protective effect of metronidazole on preterm birth and low birth weight was not confirmed.

AB - INTRODUCTION - The primary aim of the study was to investigate the possibility of a teratogenic effect of vaginal metronidazole treatment during pregnancy. MATERIALS AND METHODS - Various congenital abnormalities and all (1-3) their matched controls were analysed in the population-based database of the Hungarian Case-Control Surveillance of Congenital Abnormalities between 1980 and 1996. The study group comprised 38151 pregnant women who had newborns without any congenital abnormalities (control group) and 22 843 pregnant women who had newborns or fetuses with congenital abnormalities. Main outcome measures were analysed in 22 congenital abnormalities groups. The use of metronidazole during the second and third trimesters being common, the secondary objective of the study was to analyse the effect of vaginal metronidazole treatment (500 mg of Klion) on gestational age and birth weight in the control group without congenital abnormalities. RESULTS - The prevalence of vaginal metronidazole treatment during pregnancy was 1.7% in the case group (n=388) and 1.5% in the control group (n=570) (odds ratio (OR), 1.1, 95% confidence interval (CI): 1.0-1.3). Comparisons of cases and their matched controls showed an association between vaginal metronidazole treatment during the second and third months of gestation and congenital hydrocephaly (adjusted OR with 95% CI, 10.7, 1.1-104.5), but this was only based on five cases. The analysis of metronidazole treatment reported by the physicians did not confirm this association. After metronidazole use the mean gestational age was slightly shorter (by 0.1 week) and the mean birth weight was also slightly lower (by 40g) in the treated group. CONCLUSION - This finding should only be regarded as an indication for a possible association between vaginal treatment with metronidazole during pregnancy and congenital hydrocephalus. The results showed that vaginal metronidazole treatment alone was not able to prevent a possible vaginal infection that is associated with preterm birth, and that the prevalence of low birth weight was higher among treated women. The protective effect of metronidazole on preterm birth and low birth weight was not confirmed.

KW - Birth weight

KW - Case-control study

KW - Congenital abnormalities

KW - Congenital hydrocephaly

KW - Gestational age

KW - Low birth weight

KW - Metronidazole

KW - Preterm birth

KW - Vaginal administration

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VL - 16

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EP - 648

JO - Lege Artis Medicinae

JF - Lege Artis Medicinae

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