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Metformin exposure in first trimester of pregnancy and risk of all or specific congenital anomalies: exploratory case-control study.

ABSTRACT: OBJECTIVE:To investigate whether exposure to metformin during the first trimester of pregnancy, for diabetes or other indications, increases the risk of all or specific congenital anomalies. DESIGN:Population based exploratory case-control study using malformed controls. Cases of 29 specific subgroups of non-genetic anomalies, and all non-genetic anomalies combined, were compared with controls (all other non-genetic anomalies or genetic syndromes). SETTING:11 EUROmediCAT European congenital anomaly registries surveying 1?892?482 births in Europe between 2006 and 2013. PARTICIPANTS:50?167 babies affected by congenital anomaly (41?242 non-genetic and 8925 genetic) including live births, fetal deaths from 20 weeks' gestation, and terminations of pregnancy for fetal anomaly. MAIN OUTCOME MEASURE:Odds ratios adjusted for maternal age, registry, multiple birth, and maternal diabetes status. RESULTS:168 babies affected by congenital anomaly (141 non-genetic and 27 genetic) were exposed to metformin, 3.3 per 1000 births. No evidence was found for a higher proportion of exposure to metformin during the first trimester among babies with all non-genetic anomalies combined compared with genetic controls (adjusted odds ratio 0.84, 95% confidence interval 0.55 to 1.30). The only significant result was for pulmonary valve atresia (adjusted odds ratio 3.54, 1.05 to 12.00, compared with non-genetic controls; 2.86, 0.79 to 10.30, compared with genetic controls). CONCLUSIONS:No evidence was found for an increased risk of all non-genetic congenital anomalies combined following exposure to metformin during the first trimester, and the one significant association was no more than would be expected by chance. Further surveillance is needed to increase sample size and follow up the cardiac signal, but these findings are reassuring given the increasing use of metformin in pregnancy.

SUBMITTER: Given JE

PROVIDER: S-EPMC6016021 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Metformin exposure in first trimester of pregnancy and risk of all or specific congenital anomalies: exploratory case-control study.

Given Joanne E JE Loane Maria M Garne Ester E Addor Marie-Claude MC Bakker Marian M Bertaut-Nativel Bénédicte B Gatt Miriam M Klungsoyr Kari K Lelong Nathalie N Morgan Margery M Neville Amanda J AJ Pierini Anna A Rissmann Anke A Dolk Helen H

BMJ (Clinical research ed.) 20180625

<h4>Objective</h4>To investigate whether exposure to metformin during the first trimester of pregnancy, for diabetes or other indications, increases the risk of all or specific congenital anomalies.<h4>Design</h4>Population based exploratory case-control study using malformed controls. Cases of 29 specific subgroups of non-genetic anomalies, and all non-genetic anomalies combined, were compared with controls (all other non-genetic anomalies or genetic syndromes).<h4>Setting</h4>11 EUROmediCAT Eu ...[more]

PMID: 29941493

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Project description:BackgroundEvidence regarding the association between acute respiratory infections during pregnancy and congenital anomalies in babies, is limited and conflicting. The aim of this study was to examine the association between acute respiratory infections during the first trimester of pregnancy and congenital anomalies in babies using record linkage.MethodsWe linked a perinatal register to hospitalisation and disease notifications in the Australian state of New South Wales (NSW) between 2001 to 2016. We quantified the risk of congenital anomalies, identified from the babies' linked hospital record in relation to notifiable respiratory and other infections during pregnancy using generalized Estimating Equations (GEE) adjusted for maternal sociodemographic and other characteristics.ResultsOf 1,453,037 birth records identified from the perinatal register between 2001 and 2016, 11,710 (0.81%) mothers were hospitalised for acute respiratory infection, 2850 (0.20%) had influenza and 1011 (0.07%) had high risk infections (a record of cytomegalovirus, rubella, herpes simplex, herpes zoster, toxoplasmosis, syphilis, chickenpox (varicella) and zika) during the pregnancy. During the first trimester, acute respiratory infection, influenza and high-risk infections were reported by 1547 (0.11%), 399 (0.03%) and 129 (0.01%) mothers. There were 15,644 (1.08%) babies reported with major congenital anomalies, 2242 (0.15%) with cleft lip/ plate, 7770 (0.53%) with all major cardiovascular anomalies and 1746 (0.12%) with selected major cardiovascular anomalies. The rate of selected major cardiovascular anomalies was significantly higher if the mother had an acute respiratory infection during the first trimester of pregnancy (AOR 3.64, 95% CI 1.73 to 7.66). The rates of all major congenital anomalies and all major cardiovascular anomalies were also higher if the mother had an acute respiratory infection during the first trimester of pregnancy, however the difference was no statistically significant. Influenza during the first trimester was not associated with major congenital anomalies, selected major cardiovascular anomalies or all major cardiovascular anomalies in this study.ConclusionThis large population-based study found severe acute respiratory infection in first trimester of pregnancy was associated with a higher risk of selected major cardiovascular anomalies in babies. These findings support measures to prevent acute respiratory infections in pregnant women including through vaccination.

Dataset Information

Metformin exposure in first trimester of pregnancy and risk of all or specific congenital anomalies: exploratory case-control study.

Publications

Metformin exposure in first trimester of pregnancy and risk of all or specific congenital anomalies: exploratory case-control study.

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