Status:
RECRUITING
COVID-19 Vaccines International Pregnancy Exposure Registry
Lead Sponsor:
Pregistry
Conditions:
Covid19
Eligibility:
FEMALE
18-50 years
Brief Summary
The objective of the COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER) is to evaluate obstetric, neonatal, and infant outcomes among women vaccinated during pregnancy with a COVID-...
Detailed Description
Rationale and background: COVID-19 vaccines will be used in pregnant populations. Scientific evidence regarding their safety for pregnant women and the developing fetus is lacking. Objective: The obj...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
6000 Patients enrolled
Trial Details
Trial ID
NCT04705116
Start Date
June 1 2021
End Date
December 31 2026
Last Update
September 26 2025
Active Locations (1)
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1
Pregistry
Los Angeles, California, United States, 90045