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

NCT ID: NCT05663762

Last Updated: 2024-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

136500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2024-02-01

Brief Summary

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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

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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.

Conditions

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Pregnancy Related

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Pre-pandemic pregnancy and birth

Live hospital births that occurred Jan 1 - Mar 31 2019

No interventions assigned to this group

Pregnant and gave birth during the pandemic but before widespread COVID-19 vaccine availability

Live hospital births that occurred Jan 1 - Mar 31 2021

No interventions assigned to this group

Pregnant and gave birth during the pandemic and after widespread COVID-19 vaccine availability

Live hospital births that occurred Jan 1 - Mar 31 2022

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of British Columbia

OTHER

Sponsor Role collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Meredith Vanstone, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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University of British Columbia

Vancouver, British Columbia, Canada

Site Status

McMaster University

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 34092185 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37561748 (View on PubMed)

Correia RH, Greyson D, Kirkwood D, Darling EK, Pahwa M, Bayrampour H, Jones A, Kuyvenhoven C, Liauw J, Vanstone M. New perinatal mental health conditions diagnosed during COVID-19: a population-based, retrospective cohort study of birthing people in Ontario. Arch Womens Ment Health. 2025 Aug;28(4):881-894. doi: 10.1007/s00737-024-01534-1. Epub 2024 Nov 19.

Reference Type DERIVED
PMID: 39560777 (View on PubMed)

Greyson D, Correia R, Howard M, Darling EK, Kirkwood D, Davis A, Mniszak C, Jones A, Molinaro M, Vanstone M. SARS-CoV-2, Tdap, and influenza vaccination during pregnancy from 2019 to 2022 in Ontario, Canada: a population-based retrospective cohort study. CMAJ. 2024 Sep 30;196(32):E1100-E1113. doi: 10.1503/cmaj.231522.

Reference Type DERIVED
PMID: 39353631 (View on PubMed)

Other Identifiers

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CovPreg2022

Identifier Type: -

Identifier Source: org_study_id

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