RecruitingNCT04705116

COVID-19 Vaccines International Pregnancy Exposure Registry

COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER)

Sponsor

Pregistry

Enrollment

6,000 participants

Start Date

Jun 1, 2021

Study Type

OBSERVATIONAL

Conditions

COVID19

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-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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This international registry tracks outcomes in pregnant women who received a COVID-19 vaccine either during pregnancy or within 30 days before their last menstrual period, and compares them to pregnant women who did not receive the vaccine. Because COVID-19 vaccines were developed and distributed rapidly, long-term safety data in pregnant people was initially limited. This registry collects real-world data to understand whether COVID-19 vaccination during pregnancy affects birth outcomes, maternal health, or infant health. The study enrolls pregnant women 18 and older from countries where ethics approval has been granted. Both vaccinated and unvaccinated pregnant women are eligible to participate. You may be eligible if: - You are 18 or older and currently pregnant - You received at least one COVID-19 vaccine dose during pregnancy or within 30 days before your last menstrual period (vaccinated group) — OR you have not received any COVID-19 vaccine during pregnancy (comparison group) - You reside in a country where the study has ethics approval You may NOT be eligible if: - You are not pregnant at the time of enrollment - You are under 18 years of age Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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