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

Sponsor

McMaster University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05663762

Collaborator

University of British Columbia (Other), Canadian Institutes of Health Research (CIHR) (Other)

270,000

Enrollment

Locations

Anticipated Duration (Months)

135000

Patients Per Site

6736.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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:

Describe differences between Pre-Pandemic (05/01/2019-12/01/2019 births), Early-Pandemic (05/01/2020-12/01/2020 births), and Late-Pandemic (05/01/2021-12/01/2021 births) 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)
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

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Related

Detailed Description

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 and preliminary data from a small sample of Ontario participants was collected in Fall 2022. Qualitative data collection in both provinces is currently (December 2022) ongoing. Study completion is anticipated for February 2024.

Study Design

Study Type:

Observational

Anticipated Enrollment :

270000 participants

Observational Model: