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临床试验/NCT05663762
NCT05663762已完成不适用

How do Perceptions of Coronavirus Disease (COVID-19) Risk Influence Health Decisions in Pregnancy?

McMaster University2 个研究点 分布在 1 个国家目标入组 136,500 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
136,500
试验地点
2
主要终点
Mental Health and Social Support

研究概览

简要总结

Pregnant people have a higher risk of severe COVID-19 disease. Pregnant people have been disproportionately impacted by COVID-19 infection control policies, which have resulted in higher rates of intimate partner violence, mental health distress, employment and income loss. This project examines the impact of accumulated individual health decisions, describing how perinatal healthcare use and outcomes changed during the COVID-19 pandemic.

Objectives, questions and hypotheses

This research study has two objectives:

  1. Describe differences between three groups of pregnant persons classified by the date they gave birth: 01/01/2019-03/31/2019 (2019 birth group), 01/01/2021-03/31/2021 (2021 birth group), and 01/01/2022-03/31/2022 (2022 birth group) pregnancy cohorts in Ontario and British Columbia relative to key outcomes and quality of care indicators related to vaccination, perinatal care, and mental health. Examine the differential impacts on racialized and low-income pregnant people. (Quantitative strand)
  2. Understand how pregnant people's perceptions of COVID-19 risk and pandemic circumstances influenced their decision-making about key elements of pregnancy, including vaccination, perinatal care, social support and mental health. (Qualitative strand)

Research questions and hypotheses have been operationalized according to our three themes:

Theme 1: Vaccination Theme 2: Perinatal Care Theme 3: Mental Health and Social Support

详细描述

This project examines individual health decisions that occur within these structural environments, describing their accumulated impact on key pregnancy outcomes and care indicators related to three themes: vaccination, perinatal care, social supports and mental health. The decisions made during pregnancy have longitudinal impacts on the life of the pregnant person, future child, and family.(1) Given evidence of the particularly difficult situations faced by pregnant people, and the importance of these health decisions, it is important to understand how pandemic circumstances have shaped health decision-making. Understanding how and why pregnant people are making health decisions allows for better clinical and social support as the pandemic endures, and will inform future policy planning. This project is a cross-provincial, parallel mixed-methods study, with thematic data integration at the design and interpretation stages. Ontario and British Columbia were chosen as the two provinces of study because they both experienced a significant impact from COVID-19, both have access to comprehensive administrative health data, and a large number of live births each year.

This study was funded in late February 2022. The quantitative cohort creation plans and data access requests were finalized in late Fall 2022. Qualitative data collection was piloted in Summer 2022, data collection was complete in both provinces August 2023. Study completion is anticipated for February 2024.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • live, in-hospital birth during the investigators' timeframes of interest
  • valid birth date or death date in administrative records
  • be of female sex
  • been eligible for Ontario Health Insurance Plan in Ontario or Medical Services Plan in British Columbia for the entirety of their pregnancy period

排除标准

  • birth outside of a hospital
  • stillbirth

结局指标

主要结局

Mental Health and Social Support

时间窗: Specified groups from Jan 1 2019 to March 31 2022

Were the rates of clinical diagnosis for new depression, anxiety, and adjustment disorders during pregnancy different between 2019, 2021, and 2022 birth groups?

Perinatal Care

时间窗: Specified groups from Jan 1 2019 to March 31 2022

Were rates of in-person perinatal care different between 2019, 2021, and 2022 birth groups? Outcomes: Gestational diabetes screening, post-partum length of stay

Vaccination

时间窗: Specified groups from Jan 1 2019 to March 31 2022 (Tdap); Specified groups from Jan 1 2022 to March 31 2022 (Covid-19)

Were rates of Tdap vaccination different between 2019, 2021, and 2022 birth groups? Outcomes: Tdap (Ontario only) and COVID-19 vaccination rates

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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