NCT05663762

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

Completed Last updated 20 March 2024

What this trial tests

trial in Pregnancy Related in 136,500 participants. Completed in 1 February 2024.

Timeline

1 June 2022

Primary endpoint
1 January 2024

1 February 2024

Quick facts

Lead sponsor	McMaster University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	136,500
Start date	1 June 2022
Primary completion	1 January 2024
Estimated completion	1 February 2024
Sites	2 locations across Canada

Conditions studied

• Pregnancy Related — all drugs for Pregnancy Related →

Sponsor

McMaster University

Who can join

Eligibility, female only, with Pregnancy Related. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. How do perceptions of Covid-19 risk impact pregnancy-related health decisions? A convergent parallel mixed-methods study protocol.
   Vanstone M, Correia RH, Howard M, Darling E, et al · · 2023 · cited 7× · PMID 37561748 · DOI 10.1371/journal.pone.0288952
2. New perinatal mental health conditions diagnosed during COVID-19: a population-based, retrospective cohort study of birthing people in Ontario.
   Correia RH, Greyson D, Kirkwood D, Darling EK, et al · · 2025 · cited 3× · PMID 39560777 · DOI 10.1007/s00737-024-01534-1
3. SARS-CoV-2, Tdap, and influenza vaccination during pregnancy from 2019 to 2022 in Ontario, Canada: a population-based retrospective cohort study.
   Greyson D, Correia R, Howard M, Darling EK, et al · · 2024 · cited 3× · PMID 39353631 · DOI 10.1503/cmaj.231522
4. Assessing the impact of the COVID-19 pandemic on uptake and experiences of gestational diabetes mellitus screening in Ontario: A parallel convergent mixed-methods study.
   Hadid D, Correia RH, McDonald SD, Darling EK, et al · · 2024 · PMID 39729523 · DOI 10.1371/journal.pone.0315983
5. How do perceptions of Covid-19 risk impact pregnancy-related health decisions? A convergent parallel mixed-methods study protocol
   Vanstone M, Correia RH, Howard M, Darling E, et al · · 2023 · DOI 10.1101/2023.07.10.23292463