COVID-19 vaccination effects on pregnant individuals and their newborns
Pregnant and Lactating Individuals & Newborns COVID-19 Vaccination (PLAN-V): Prospective Cohort Study
This study is testing how safe and effective COVID-19 vaccines are for pregnant people and their babies to help guide health recommendations.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Sex | Female |
| Sponsor | Ottawa Hospital Research Institute Academic / other |
| Locations | 7 sites (Hamilton, Ontario and 6 other locations) |
| Trial ID | NCT05115617 on ClinicalTrials.gov |
What this trial studies
The PLAN-V Study is a prospective, longitudinal study based in Ontario that focuses on pregnant individuals who have received the COVID-19 vaccine. It aims to collect extensive biosamples and data from these individuals and their infants throughout the antenatal, delivery, and postpartum periods. The study's objectives include evaluating the immunogenicity and safety of COVID-19 vaccines in pregnant individuals, comparing immune responses between vaccinated and non-vaccinated groups, and assessing health outcomes for both mothers and newborns. This research is crucial for informing public health recommendations and supporting evidence-based decision-making for families and healthcare providers.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant individuals aged 16 years and older who are at least 7 weeks pregnant and planning to receive a COVID-19 vaccine.
Not a fit: Patients who are fully vaccinated against COVID-19 or have major fetal concerns will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safety and efficacy of COVID-19 vaccinations for pregnant individuals and their infants.
How similar studies have performed: Other studies have shown success in evaluating vaccine safety and immunogenicity in pregnant populations, making this approach both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women/Individuals ≥ 16 years of age who are ≥7 0/7 weeks' gestation on the day of enrollment * Capacity to provide informed consent and to comprehend and comply with the study requirements * Planning to deliver at a participating site hospital * Planning to receive or have previously received one-dose of a Health Canada approved COVID-19 vaccine (any product, any number of doses) during the current pregnancy Exclusion Criteria: * Cases with known major fetal concerns * Women/Individuals who are fully vaccinated against COVID-19 * Women/Individuals who are pregnant due to surrogacy, or planning to give their child up for adoption * Women/Individuals with a non-viable pregnancy (e.g., ectopic)
Where this trial is running
Hamilton, Ontario and 6 other locations
- Hamilton Health Sciences Corporation — Hamilton, Ontario, Canada (Not_yet_recruiting)
- Kingston Health Sciences Centre — Kingston, Ontario, Canada (Not_yet_recruiting)
- London Health Sciences — London, Ontario, Canada (Not_yet_recruiting)
- The Ottawa Hospital - General — Ottawa, Ontario, Canada (Recruiting)
- The Ottawa Hospital - Civic Campus — Ottawa, Ontario, Canada (Recruiting)
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Not_yet_recruiting)
- St. Michael's Hospital — Toronto, Ontario, Canada (Not_yet_recruiting)
Study contacts
- Principal investigator: Darine El-Chaâr, MD, MSc — The Ottawa Hospital
- Study coordinator: Stephanie Boyd, MBA
- Email: sboyd@ohri.ca
- Phone: 613-737-8899
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.