COVID-19 Vaccines International Pregnancy Exposure Registry

Launched by PREGISTRY · Jan 9, 2021

Keywords

ClinConnect Summary

The COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER) is a study designed to understand how receiving a COVID-19 vaccine during pregnancy affects both mothers and their babies. Researchers want to learn about various health outcomes for mothers, such as complications during pregnancy and childbirth, as well as outcomes for their newborns, including any birth defects or health issues in the first year of life. The study will compare the experiences of pregnant women who have received a COVID-19 vaccine to those who have not been vaccinated during their pregnancy.

To be eligible for this study, women must be at least 18 years old and currently pregnant. They should either have received at least one dose of a COVID-19 vaccine during their pregnancy or within 30 days before their last menstrual period, or they should have not received any COVID-19 vaccines during that time. Participants will be asked to sign a consent form and complete a questionnaire about their health and vaccination status. This study aims to gather important information that could help improve understanding of the safety of COVID-19 vaccines for pregnant women and their babies.

Gender

FEMALE

Eligibility criteria

• Inclusion criteria:
• Vaccinated population:
• • Pregnant at time of enrollment
• • Age ≥18 years at time of enrollment
• • Signed the informed consent form and submitted the baseline module "COVID-19 Vaccination During This Pregnancy"
• • Received at least one dose of a COVID-19 vaccine during pregnancy or within the 30 days prior to the first day of the LMP
• • Resident of a country where a Central Institutional Review Board (IRB) or Ethics Committee provided approval to conduct the study or clearance that approval is not required to conduct the study
• • Efforts will be made to obtain documentary evidence of COVID-19 vaccination.
• Comparison population:
• • Pregnant at time of enrollment
• • Age ≥18 years at time of enrollment
• • Signed the informed consent form and submitted the minimum required data in the initial baseline questionnaire
• • Have not received a COVID-19 vaccine during pregnancy or within the 30 days prior to the first day of the LMP
• • Resident of a country where a Central IRB or Ethics Committee provided approval to conduct the study or clearance that approval is not required to conduct the study
• Exclusion criteria:
• • Not pregnant at time of enrollment
• • Age \<18 years at time of enrollment