BACKGROUND AND AIMS: Opioid maintenance treatment (OMT) is recommended to opioid-dependent females during pregnancy. However, it is not clear which medication should be preferred. We aimed to compare neonatal outcomes after prenatal exposure to methadone (M) and buprenorphine (B) in two European countries. DESIGN: Nation-wide register-based cohort study using personalized IDs assigned to all citizens for data linkage. SETTING: The Czech Republic (2000-14) and Norway (2004-13). [Correction added after online publication on 26 April 2018: The Czech Republic (2000-04) corrected to (2000-14).] PARTICIPANTS: Opioid-dependent pregnant Czech (n = 333) and Norwegian (n = 235) women in OMT who received either B or M during pregnancy and their newborns. MEASUREMENTS: We linked data from health registries to identify the neonatal outcomes: gestational age, preterm birth, birth weight, length and head circumference, small for gestational age, miscarriages and stillbirth, neonatal abstinence syndrome (NAS) and Apgar score. We performed multivariate linear regression and binary logistic regression to explore the associations between M and B exposure and outcomes. Regression coefficient (β) and odds ratio (OR) were computed. FINDINGS: Most neonatal outcomes were more favourable after exposure to B compared with M, but none of the differences was statistically significant. For instance, in the multivariate analysis, birth weight was β = 111.6 g [95% confidence interval (CI) = -10.5 to 233.6 and β = 83.1 g, 95% CI = -100.8 to 267.0] higher after B exposure in the Czech Republic and Norway, respectively. Adjusted OR of NAS for B compared with M was 0.94 (95% CI = 0.46-1.92) in the Norwegian cohort. CONCLUSIONS: Two national cohorts of women receiving opioid maintenance treatment during pregnancy showed small but not statistically significant differences in neonatal outcomes in favour of buprenorphine compared with methadone.

Department of Addictology 1st Faculty of Medicine Charles University Prague Czech Republic

Department of Addictology 1st Faculty of Medicine Charles University Prague Czech Republic National Monitoring Centre for Drugs and Addiction Office of the Government of the Czech Republic Prague Czech Republic

Norwegian institute of Public Health Oslo Norway

Norwegian institute of Public Health Oslo Norway Department of Global Public Health and Primary Care University of Bergen Bergen Norway

Norwegian institute of Public Health Oslo Norway Norwegian Centre for Addiction Research at the University of Oslo Oslo Norway

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