COVID-19 Vaccines International Pregnancy Exposure Registry

ConditionCovid19
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorPregistry

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Not pregnant at time of enrollment

Age <18 years at time of enrollment

Trial design

Treatments tested in this trial

  • COVID-19 vaccine

Treatment groups

6,000 Participants
are divided into 2 treatment groups

Sponsors and collaborators