COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER)
Pregistry
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.
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 objective of the COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER) is to 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…
Eligibility
- Age range
- 18–50 years
- Sex
- Female
- Healthy volunteers
- Yes
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 eviden…
Interventions
- BiologicalCOVID-19 vaccine
At least one dose of a COVID-19 vaccine.
Location
- PregistryLos Angeles, California