Study identification

PURI

https://redirect.ema.europa.eu/resource/40543

EU PAS number

EUPAS39226

Study ID

40543

Official title and acronym

Registry for pregnant women exposed to SARS-CoV-2 (COVID-19, CONSIGN study) (COVI-PREG)

DARWIN EU® study

No

Study countries

Argentina
Belgium
Brazil
Chile
Colombia
Egypt
France
French Guiana
Germany
Ireland
Israel
Italy
Mexico
Peru
Portugal
Spain
Switzerland
United Kingdom
United States

Study description

The COVI-PREG registry aims to collect data to understand the natural history of the SARS-CoV-2 among pregnant women and the impact on maternal, pregnancy and neonatal outcomes. The COVI-PREG project is part of the Covid-19 infectiOn aNd medicineS In preGNancy (CONSIGN) project that study the impact of COVID-19 infection and medicines in pregnancy, as work package 3. The mains objectives are to describe, among positive SARS-CoV-2 pregnant women, the use of medicines, the impact of medicine use on COVID-19 severity and on pregnancy and neonatal outcome.

Study status

Finalised
Research institution and networks

Institutions

Multiple centres: 150 centres are involved in the study

Contact details

Alice Panchaud

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Other

More details on funding

Swiss Public health office, CHUV, UNIBe
Study protocol
Initial protocol

COVIDPREG_register_protocol_ExternalPartnairs

English (356.82 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

Non-EU RMP only