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

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

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Key information

Conditions

Pregnancy Related COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

Female

Study type

Observational

Primary location

University of British Columbia, Vancouver, British Columbia, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

birth outside of a hospital
stillbirth

Treatment and study plan

Primary outcomes

Vaccination

Time frame: 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
Perinatal Care

Time frame: 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
Mental Health and Social Support

Time frame: 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?

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

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

Registry information

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Dec 23, 2022
Registry last updated: Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed