Does Tramadol Exposure in Pregnancy Increase the Risk of Miscarriage or Congenital Malformations?
BACKGROUND AND PURPOSE:
Sørensen et al. (Obstetrics & Gynecology, 2022) assessed whether exposure to tramadol (a commonly prescribed opioid) during early pregnancy is associated with an increased risk for spontaneous abortion or major congenital malformations
Nationwide cohort study
Danish National Patient Register and the Danish Medical Birth Register
Maternal exposure to tramadol ≥1 prescription
Within the first trimester of pregnancy (duration of 12 weeks) for analyses of major congenital malformations
Within the first 22 weeks of pregnancy for the analyses of spontaneous abortions
Pregnancies exposed to tramadol were matched 1:4 with unexposed pregnancies using propensity score matching
Cox proportional hazards regression was used to estimate the hazard ratios (HR) of spontaneous abortion
Relative risk ratios for major congenital malformations were estimated
Major congenital malformation
Analyses of spontaneous abortion: 36,467 pregnancies
Tramadol exposed: 7310
Analyses of major congenital malformations: 18,907 pregnancies
Tramadol exposed: 3796
There was no significant risk of spontaneous abortion associated with tramadol exposure
Tramadol exposed: 12.2%
HR 1.06 (95% CI, 0.99 to 1.14)
There was also no significant risk of major congenital malformation associated with tramadol exposure
Tramadol exposed: 4.0%
RR 1.04 (95% CI, 0.87 to 1.24)
There does not seem to be a link between tramadol exposure in pregnancy and spontaneous abortion or major congenital malformations
Limitations include lack of some relevant baseline variables such as alcohol consumption
The authors state
Current international guidelines do not consider tramadol to be contraindicated during pregnancy, which our study supports
However, physicians who treat pregnant women should always consider risks and benefits of tramadol exposure in the specific clinical context, because sufficient pain treatment is important, but risks such as neonatal abstinence syndrome are well described
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