Singal Deepa, Dahl Lindsey, Brownell Marni, Dormuth Colin, Bolton James M, Enns Jennifer E, Hanlon-Dearman Ana, Katz Alan, Katz Laurence Y, Kelly Lauren E, Leong Christine, McGrail Kimberlyn, Nickel Nathan C, Ruth Chelsea, Dahl Matthew, Kim Jason, Chateau Dan
Department of Community Health Sciences, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada
Department of Community Health Sciences, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.
BMJ Open. 2025 May 2;15(5):e097657. doi: 10.1136/bmjopen-2024-097657.
Opioids are prescribed to manage pain. Approximately 1 in 20 pregnant women in Canada are prescribed opioids during the prenatal period, which may occur concurrently with other psychotropic drug use. The health implications of the independent and concurrent prenatal use of these drugs are not fully understood; however, adverse neonatal and longer-term outcomes have been suggested. This protocol describes a study to update the epidemiology of prenatal exposure to opioid and other psychotropic drug use during pregnancy, providing an enhanced understanding of the potential impacts on the mother and child to help inform decisions regarding prescription and use.
The retrospective cohort study design uses population-based administrative data from Manitoba and British Columbia, Canada, to investigate the effect of prenatal opioid and concurrent psychotropic drug use on maternal and child outcomes. All mother-child dyads from 2000/2001 to 2019/2020 (approximately 1M pairs) will be identified and assigned to exposure groups based on the number of opioid and other psychotropic drug dispensations to the mother during the prenatal period. Maternal sociodemographic characteristics, prescribing patterns, short- and long-term child health and education outcomes and maternal outcomes will be examined.
The study was approved by the University of Manitoba Human Research Ethics Board (No. HS24397 - H2020:470) and the University of British Columbia Clinical Research Ethics Board (No. H21-02262). The study will generate findings that will add to the growing body of evidence of potential short- and long-term adverse effects on children exposed to these drugs prenatally and will help to inform safe prescribing guidelines during pregnancy. Results will be published in peer-reviewed journals.
阿片类药物用于控制疼痛。在加拿大，约二十分之一的孕妇在孕期会被开具阿片类药物处方，这可能与其他精神药物的使用同时发生。这些药物在孕期单独使用及同时使用对健康的影响尚未完全明确；然而，已有研究表明可能会出现不良的新生儿及长期后果。本方案描述了一项研究，旨在更新孕期阿片类药物及其他精神药物暴露的流行病学情况，加深对其对母婴潜在影响的理解，以辅助有关处方和使用的决策。
这项回顾性队列研究采用来自加拿大曼尼托巴省和不列颠哥伦比亚省基于人群的行政数据，以调查孕期阿片类药物及同时使用精神药物对母婴结局的影响。将确定2000/2001年至2019/2020年期间的所有母婴对（约100万对），并根据孕期母亲阿片类药物及其他精神药物的配药数量将其分为暴露组。将检查母亲的社会人口统计学特征、处方模式、儿童短期和长期健康及教育结局以及母亲结局。
该研究已获得曼尼托巴大学人类研究伦理委员会（编号HS24397 - H2020:470）和英属哥伦比亚大学临床研究伦理委员会（编号H21 - 02262）的批准。该研究将产生的结果将补充越来越多的证据，证明产前接触这些药物对儿童可能产生短期和长期的不良影响，并将有助于为孕期安全处方指南提供参考。研究结果将发表在同行评审期刊上。
