Study identification

PURI

https://redirect.ema.europa.eu/resource/46745

EU PAS number

EUPAS39096

Study ID

46745

Official title and acronym

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

DARWIN EU® study

No

Study countries

Australia
Bulgaria
Canada
Colombia
Croatia
Cyprus
Denmark
Germany
Greece
Hong Kong
Italy
Korea, Republic of
Malaysia
Mexico
New Zealand
Nigeria
Philippines
Romania
Singapore
Slovakia
Slovenia
South Africa
United Kingdom
United States

Study description

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.

Study status

Ongoing
Research institutions and networks

Institutions

Pregistry
First published:
01/02/2024
Institution

Contact details

Diego Wyszynski

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

AstraZeneca, Janssen, Novavax, Sanofi
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)