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

NCT05663762 | Completed

• 1 other identifier: CovPreg2022
• Study Type: observational
• Target: 136,500
• Locations: 1 country
• Sites: 2

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. 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. 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)

Conditions

Pregnancy Related

Keywords

pregnancy; healthcare use; COVID-19; administrative data; qualitative research

Outcome Measures

Primary Outcomes (3)

• Vaccination

  Were rates of Tdap vaccination different between 2019, 2021, and 2022 birth groups? Outcomes: Tdap (Ontario only) and COVID-19 vaccination rates

  Specified groups from Jan 1 2019 to March 31 2022 (Tdap); Specified groups from Jan 1 2022 to March 31 2022 (Covid-19)

• Perinatal Care

  Were rates of in-person perinatal care different between 2019, 2021, and 2022 birth groups? Outcomes: Gestational diabetes screening, post-partum length of stay

  Specified groups from Jan 1 2019 to March 31 2022

• Mental Health and Social Support

  Were the rates of clinical diagnosis for new depression, anxiety, and adjustment disorders during pregnancy different between 2019, 2021, and 2022 birth groups?

  Specified groups from Jan 1 2019 to March 31 2022

Study Arms (3)

Pre-pandemic pregnancy and birth

Live hospital births that occurred Jan 1 - Mar 31 2019

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

Live hospital births that occurred Jan 1 - Mar 31 2021

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

Live hospital births that occurred Jan 1 - Mar 31 2022

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• birth outside of a hospital
• stillbirth

Sponsors & Collaborators

• McMaster University: lead
• University of British Columbia: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

University of British Columbia

Vancouver, British Columbia, V6T 1Z4, Canada

Location

McMaster University

Hamilton, Ontario, L8P1H6, Canada

Location

Related Publications (4)

• 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.

  PMID: 34092185 BACKGROUND

• 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.

  PMID: 37561748 BACKGROUND

• 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.

  PMID: 39560777 DERIVED

• 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.

  PMID: 39353631 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Meredith Vanstone, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: December 23, 2022
• Study Start: June 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: February 1, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

CA (2)