Canadian perinatal opioid project: a protocol for a national health data system.

Introduction: Opioids are widely used during pregnancy and can lead to health complications for pregnant people, parents and their children. Yet, little is known about the long- and short-term effects of perinatal opioid exposures on health outcomes in Canada. Evidence is needed to inform optimal support for maternal and child health following perinatal opioid exposures.

Aim: We aim to develop the Canadian Perinatal Opioid Project, a pan-Canadian federated health data system to capture perinatal opioid exposures across multiple provinces, along with subsequent maternal and child health outcomes.

Methods And Analysis: This health data system uses population-based administrative health records from Alberta, British Columbia, Manitoba, Ontario and Saskatchewan, each with two population-based cohorts: (1) all pregnancies among people aged 12-49 years, 2013-2023 and (2) liveborn infants from these pregnancies. Pregnant people will be followed for 1 year after the end of pregnancy; live births will be followed for 8 years. Data will be obtained from outpatient prescription opioid records, mother-infant linked hospitalisation records, emergency department visits, outpatient physician visits, birth registries and vital statistics. This work is being conducted in collaboration with Indigenous and non-Indigenous people with lived/living experience of perinatal opioid use and knowledge users.

Analysis: We will use descriptive statistics to describe incidence and cohort characteristics and Poisson regression to assess annual trends. Patient-level analysis will occur in each province, and province-level aggregated results will be meta-analysed.

Ethics And Dissemination: Ethics approval was granted by research ethics boards at the University of British Columbia (H24-03406), University of Calgary (REB24-1721), University of Manitoba (HS26640), University of Toronto (46764) and University of Saskatchewan (5348). We will develop knowledge dissemination plans and products with people with lived/living experience of perinatal opioid use and knowledge users. Health data indicators will be featured in an open-access online dashboard. We expect to share methods and research findings through peer-reviewed publications in high-impact journals, presentations at national and international conferences, presentations to community members and knowledge users, and research summaries for the general population.