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

Study identification

• 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 institutions and networks

Institutions

Multiple centres: 150 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 24/03/2020

Study start date

Actual: 24/03/2020

Date of final study report

Planned: 31/07/2023

Actual: 27/10/2022

Sources of funding

EMA

Other

More details on funding

Swiss Public health office, CHUV, UNIBe

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only

Other study registration identification numbers and links

Trial registration number: ID 2020-00548 – Swissethics (Swiss Association of Research Ethics Committee)