Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Department of Obstetrics and Gynecology, Queen's University, Kingston, Ontario, Canada.
BMJ Open. 2022 Dec 22;12(12):e066196. doi: 10.1136/bmjopen-2022-066196.
Cannabis use in pregnancy and post partum is increasing. Accessibility to cannabis has expanded due to the legalisation of cannabis in Canada. Therefore, there is a critical need to monitor the impact of cannabis on pregnancy outcomes and infant neurodevelopment. This pilot study will assess the feasibility of modern recruitment and data collection strategies adapted to the current cannabis environment and inform the design of a multicentre prospective birth cohort.
We will establish a pregnancy and birth cohort of 50 cannabis users and 50 non-users recruited before delivery. We will follow the participants at regular visits from recruitment to 12 weeks post partum. Participants will provide demographic and socioeconomic data, report their cannabis use patterns, and provide biological samples. Biological samples include maternal and infant urine and blood, breastmilk/chestmilk, cord blood, cord tissue, placenta and meconium. All samples will be processed and stored at -80°C until analysis by immunoassay or liquid chromatography-tandem mass spectrometry to determine the presence of cannabis metabolites. In addition, partners will be invited to provide additional socioeconomic and substance use data.
Ethics was obtained from Ottawa Health Science Network Research Ethics Board through Clinical Trials Ontario (3791). Our findings will be published in peer-reviewed journals, presented at scientific conferences and shared broadly with patients, healthcare decision-makers, and project partners online and through social media.
NCT05309226.Cite Now.
怀孕期间和产后使用大麻的情况正在增加。由于加拿大大麻合法化,大麻的获取变得更加容易。因此,迫切需要监测大麻对妊娠结局和婴儿神经发育的影响。这项试点研究将评估适应当前大麻环境的现代招募和数据收集策略的可行性,并为多中心前瞻性出生队列的设计提供信息。
我们将建立一个由 50 名大麻使用者和 50 名非使用者组成的妊娠和分娩队列,在分娩前招募。我们将在定期访问中从招募开始一直跟踪参与者到产后 12 周。参与者将提供人口统计学和社会经济数据,报告他们的大麻使用模式,并提供生物样本。生物样本包括产妇和婴儿的尿液和血液、母乳/胸奶、脐带血、脐带组织、胎盘和胎粪。所有样本将在 -80°C 下处理和储存,直到通过免疫测定或液相色谱-串联质谱法分析以确定大麻代谢物的存在。此外,还将邀请伴侣提供额外的社会经济和物质使用数据。
渥太华健康科学网络研究伦理委员会通过临床试验安大略省(3791)获得了伦理。我们的研究结果将发表在同行评议的期刊上,在科学会议上展示,并通过在线和社交媒体广泛分享给患者、医疗保健决策者和项目合作伙伴。
NCT05309226.