Pregnant and Lactating Individuals & Newborns COVID-19 Vaccination Prospective Cohort Study

Launched by OTTAWA HOSPITAL RESEARCH INSTITUTE · Nov 8, 2021

Keywords

ClinConnect Summary

The PLAN-V Study is a research project taking place in Ontario that aims to understand how receiving a COVID-19 vaccine during pregnancy affects both the mother and her newborn. This study will closely follow pregnant women who have chosen to get vaccinated and will collect various health samples and information about their experiences from the time they are pregnant through delivery and after giving birth. The goal is to learn more about the vaccine's effects on the immune system and any reactions that might occur.

To participate in this study, women must be at least 16 years old, at least 7 weeks pregnant, and planning to deliver at a participating hospital. They should also be planning to receive or have already received a COVID-19 vaccine during their pregnancy. However, women who are fully vaccinated before the study, have known major concerns with their pregnancy, or are pregnant through surrogacy or planning to give their child up for adoption are not eligible. Participants can expect to provide health information and samples throughout the study, which will help researchers better understand vaccination during pregnancy.

Gender

FEMALE

Eligibility 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)