Clinical trial NCT05663762: How do Perceptions of Coronavirus Disease (COVID-19) Risk Influence Health Decisions in Pregnancy?
Official title: How do Perceptions of Coronavirus Disease (COVID-19) Risk Influence Health Decisions in Pregnancy?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Related
Keywords: pregnancy
healthcare use
COVID-19
administrative data
qualitative research
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: University of British Columbia
name: Canadian Institutes of Health Research (CIHR)
First posted: 2022-12-23
Enrollment: 136500
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our total population of Jan 1-Mar 31 births over the three-year study period is therefore approximately 105,000 in Ontario and 31,500 in British Columbia.

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:

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Vaccination
timeFrame: Specified groups from Jan 1 2019 to March 31 2022 (Tdap); Specified groups from Jan 1 2022 to March 31 2022 (Covid-19)
measure: Perinatal Care
timeFrame: Specified groups from Jan 1 2019 to March 31 2022
measure: Mental Health and Social Support
timeFrame: Specified groups from Jan 1 2019 to March 31 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Meredith Vanstone, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rockliffe L, Peters S, Heazell AEP, Smith DM. Factors influencing health behaviour change during pregnancy: a systematic review and meta-synthesis. Health Psychol Rev. 2021 Dec;15(4):613-632. doi: 10.1080/17437199.2021.1938632. Epub 2021 Jun 29.
citation: Vanstone M, Correia RH, Howard M, Darling E, Bayrampour H, Carruthers A, Davis A, Hadid D, Hetherington E, Jones A, Kandasamy S, Kuyvenhoven C, Liauw J, McDonald SD, Mniszak C, Molinaro ML, Pahwa M, Patel T, Sadik M, Sanya N, Shen K, Greyson D. How do perceptions of Covid-19 risk impact pregnancy-related health decisions? A convergent parallel mixed-methods study protocol. PLoS One. 2023 Aug 10;18(8):e0288952. doi: 10.1371/journal.pone.0288952. eCollection 2023.