Lege Artis Medicinae

[POSSIBLE TERATOGENICITY OF VAGINAL METRONIDAZOLE TREATMENT AND ITS EFFECT ON GESTATIONAL AGE AND PREVALENCE OF PRETERM BIRTH - CASE-CONTROL STUDY]

KAZY Zoltán, PUHÓ Erzsébet, CZEIZEL Endre

JULY 20, 2006

Lege Artis Medicinae - 2006;16(07)

[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 38 151 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.]

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Lege Artis Medicinae

[RISKS AND BENEFITS OF MEDICATION IN PREGNANT WOMEN]

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[The Hungarian Case-Control Surveillance System of Congenital Abnormalities can provide appropriate data for the evaluation of risk and benefits of drugs and pregnancy supplements in pregnant women. Among the main principles, the importance of time factor (the first trimester concept is outdated) and the explanation of frequent false teratogenic findings (e.g. recall bias, chance effect, etc.) are discussed. The main conclusion is that at present the exaggerated teratogenic risk of drugs is much more harmful for the fetus than the rare teratogenic effect of some drugs themselves. Medical doctors and other experts therefore need more education to know the principles and findings of modern human teratology because it may help us to have a better balance between the risks and benefits of drug use during pregnancy. On the other hand, the primary prevention of neural-tube defects and some other congenital abnormalities is demonstrated by periconceptional folic acid or folic acid-containing multivitamin supplementation. Unfortunately, this new method is used rarely and inappropriately (due to the late onset of supplementation) in Hungary.]