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

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McMaster University

Status

Completed

Conditions

Pregnancy Related

Study type

Observational

Funder types

Other

Identifiers

NCT05663762
CovPreg2022

Details and patient eligibility

About

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

Full 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, data collection was complete in both provinces August 2023. Study completion is anticipated for February 2024.

Enrollment

136,500 patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

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

Trial design

136,500 participants in 3 patient groups

Pre-pandemic pregnancy and birth
Description:
Live hospital births that occurred Jan 1 - Mar 31 2019
Pregnant and gave birth during the pandemic but before widespread COVID-19 vaccine availability
Description:
Live hospital births that occurred Jan 1 - Mar 31 2021
Pregnant and gave birth during the pandemic and after widespread COVID-19 vaccine availability
Description:
Live hospital births that occurred Jan 1 - Mar 31 2022

Trial contacts and locations

2

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Central trial contact

Meredith Vanstone, PhD; Andrea Carruthers, MHK

Data sourced from clinicaltrials.gov

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