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COVID-19 Vaccines International Pregnancy Exposure Registry
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-19 vaccine. Specifically, the C-VIPER will estimate the risk of obstetric outcomes (spontaneous abortion, antenatal bleeding, gestational diabetes, gestational hypertension, intrauterine growth restriction, postpartum hemorrhage, fetal distress, uterine rupture, placenta previa, chorioamnionitis, Caesarean delivery, COVID-19), neonatal outcomes (major congenital malformations, low birth weight, neonatal death, neonatal encephalopathy, neonatal infections, neonatal acute kidney injury, preterm birth, respiratory distress in the newborn, small for gestational age, stillbirth, COVID-19), and infant outcomes (developmental milestones \[motor, cognitive, language, social-emotional, and mental health skills\], height, weight, failure to thrive, medical conditions during the first 12 months of life, COVID-19) among pregnant women exposed to single (homologous) or mixed (heterologous) COVID-19 vaccine brand series from 30 days prior to the first day of the last menstrual period to end of pregnancy and their offspring relative to a matched reference group who received no COVID-19 vaccines during pregnancy.
Conditions:
🦠 Covid19
🗓️ Study Start (Actual) 1 June 2021
🗓️ Primary Completion (Estimated) 31 December 2026
✅ Study Completion (Estimated) 31 December 2026
👥 Enrollment (Estimated) 6000
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Los Angeles, California, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 50 Years (ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 1 January 2021
  • First Submitted that Met QC Criteria 9 January 2021
  • First Posted 12 January 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 November 2023
  • Last Update Posted 18 November 2023
  • Last Verified November 2023
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