Pregnancy RelatedNCT05663762
How do Perceptions of Coronavirus Disease (COVID-19) Risk Influence Health Decisions in Pregnancy?
An observational study of Pregnancy Related, run by McMaster University at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- How many people
- 136,500 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Jun 2022to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- birth outside of a hospital
- stillbirth
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
McMaster University
Hamilton, Ontario, L8P1H6
University of British Columbia
Vancouver, British Columbia, V6T 1Z4
About this study
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
Read more
This research study has two objectives:
- 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)
- 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
Read the 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.
- Conditions
- Pregnancy Related
- Keywords
- pregnancy, healthcare use, COVID-19, administrative data, qualitative research
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccination
Were rates of Tdap vaccination different between 2019, 2021, and 2022 birth groups? Outcomes: Tdap (Ontario only) and COVID-19 vaccination rates
Measured: 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
Measured: 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?
Measured: Specified groups from Jan 1 2019 to March 31 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start1 Jun 2022
- Primary completion1 Jan 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 136,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Meredith Vanstone, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663762
- Sponsor's protocol ID
- CovPreg2022
- Status last verified
- Mar 2024
- First submitted
- 21 Dec 2022
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34092185Vanstone 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.
PubMed 37561748Correia 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.
PubMed 39560777Greyson 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.
PubMed 39353631
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How do Perceptions of Coronavirus Disease (COVID-19) Risk Influence Health Decisions in Pregnancy?
- ClinicalTrials.gov ID
- NCT05663762
- Acronym / sponsor ID
- CovPreg2022
- Conditions
- Pregnancy Related
- Keywords
- pregnancy, healthcare use, COVID-19, administrative data, qualitative research
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136,500 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- University of British Columbia, Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 23 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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)
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- birth outside of a hospital
- stillbirth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vaccination
Time frame: Specified groups from Jan 1 2019 to March 31 2022 (Tdap); Specified groups from Jan 1 2022 to March 31 2022 (Covid-19)
Were rates of Tdap vaccination different between 2019, 2021, and 2022 birth groups? Outcomes: Tdap (Ontario only) and COVID-19 vaccination rates
Perinatal Care
Time frame: Specified groups from Jan 1 2019 to March 31 2022
Were rates of in-person perinatal care different between 2019, 2021, and 2022 birth groups? Outcomes: Gestational diabetes screening, post-partum length of stay
Mental Health and Social Support
Time frame: Specified groups from Jan 1 2019 to March 31 2022
Were the rates of clinical diagnosis for new depression, anxiety, and adjustment disorders during pregnancy different between 2019, 2021, and 2022 birth groups?
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Background: PubMed 34092185Rockliffe 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.
- Background: PubMed 37561748Vanstone 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.
- Derived from this study: PubMed 39560777Correia 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.
- Derived from this study: PubMed 39353631Greyson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meredith Vanstone, PhD principal investigator
McMaster University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by McMaster University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccination (time frame: Specified groups from Jan 1 2019 to March 31 2022 (Tdap); Specified groups from Jan 1 2022 to March 31 2022 (Covid-19)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05663762, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.