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#Grand Rounds

Opioids in the First Trimester: Is There a Risk for Congenital Malformations?

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BACKGROUND AND PURPOSE:

  • There is conflicting evidence whether opioid exposure may cause congenital malformations
  • Bateman et al. (BMJ, 2021) evaluated the risk for major congenital malformations with first trimester exposure to prescription opioids

METHODS:

  • Population based cohort study
  • Data sources
    • Publicly insured database (2000 to 2014)
    • Commercially insured database (2003 to 2015)
  • Participants
    • Pregnant women and their infants
  • Exposure
    • Prescription opioids
    • 2 or more dispensations during the first trimester
  • Study design
    • Propensity score stratification was used to adjust for potential confounders and/or proxies for confounders
    • Estimates from each database were combined using meta-analysis
  • Primary outcomes
    • Major malformations overall
    • Cardiac malformations overall | VSD | ASD | Patent foramen ovale
    • NTD, clubfoot, and oral cleft

RESULTS:

  • 1,602,580 publicly insured women | 1,177,676 commercially insured women
    • Publicly insured women (Medicaid): 4.4%
    • Commercially insured (MarketScan) women: 1.1%
  • Absolute risk of malformations overall
    • Publicly insured cohort
      • Exposed: 41.0 per 1000 pregnancies (95% CI, 39.5 to 42.5)
      • Unexposed: 32.0 per 1000 pregnancies (95% CI, 31.7 to 32.3)
    • Commercially insured cohort
      • Exposed: 42.6 per 1000 pregnancies (95% CI, 39.0 to 46.1)
      • Unexposed: 37.3 per 1000 pregnancies (95% CI, 37.0 to 37.7)
  • Relative risk (RR) estimates were higher for all outcomes with exposure, but shifted toward the null after adjustment
    • Malformations overall: RR 1.06 (95% CI, 1.02 to 1.10)
    • Cardiovascular malformations: RR 1.09 (95% CI, 1.00 to 1.18)
    • Ventricular septal defect: RR 1.07 (95% CI, 0.95 to 1.21)
    • Atrial septal defect/patent foramen ovale: RR 1.04 (95% CI,  0.88 to 1.24)
    • Neural tube defect: RR 0.82 (95% CI, 0.53 to 1.27)
    • Clubfoot: RR 1.06 (95% CI, 0.88 to 1.28)
  • There was a higher risk of cleft palate: RR 1.62 (95% CI, 1.23 to 2.14)

CONCLUSION:

  • Prescription opioid use in the first trimester of pregnancy is generally not associated with major congenital malformations
    • However, there may be a small increased risk of cleft palate
  • Limitations include observational study design that carries a risk for risidual confounding
  • The authors conclude

The results inform the selection of analgesic drugs for women who are pregnant and women of reproductive age who might inadvertently become pregnant 

Learn More – Primary Sources:

Association of first trimester prescription opioid use with congenital malformations in the offspring: population based cohort study

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