Actively Recruiting
COVID-19 Vaccines International Pregnancy Exposure Registry
Led by Pregistry · Updated on 2025-09-26
6000
Participants Needed
1
Research Sites
291 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
COVID-19 Vaccines International Pregnancy Exposure Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant at time of enrollment
- Age 18 years or older at time of enrollment
- Signed the informed consent form and submitted required baseline data
- For vaccinated group: Received at least one dose of a COVID-19 vaccine during pregnancy or within 30 days prior to the first day of the last menstrual period
- For comparison group: Have not received a COVID-19 vaccine during pregnancy or within 30 days prior to the first day of the last menstrual period
- Resident of a country where Central Institutional Review Board or Ethics Committee approval or clearance is obtained
You will not qualify if you...
- Not pregnant at time of enrollment
- Under 18 years of age at time of enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Pregistry
Los Angeles, California, United States, 90045
Actively Recruiting
Research Team
C
Cheryl Renz, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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