International Registry of Coronavirus Exposure in Pregnancy (IRCEP)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/46740
• EU PAS number:
  EUPAS37360
• Study ID:
  46740
• Official title and acronym:
  International Registry of Coronavirus Exposure in Pregnancy (IRCEP)
• DARWIN EU® study:
  No
• Study countries:
  Argentina

  Australia

  Austria

  Belgium

  Brazil

  Canada

  Chile

  Colombia

  Denmark

  France

  Germany

  Ghana

  Greece

  India

  Ireland

  Israel

  Italy

  Japan

  Kenya

  Mexico

  Netherlands

  New Zealand

  Nigeria

  Pakistan

  Portugal

  Russian Federation

  South Africa

  Spain

  United Kingdom

  United States
• Study description:
  The International Registry of Coronavirus Exposure in Pregnancy (IRCEP) aims to describe the natural history of COVID-19 in pregnant women and to estimate the relative risk of major adverse obstetric and neonatal outcomes among women with varying degrees of severity and of timing of COVID-19 exposure and their offspring, respectively.
• Study status:
  Finalised

Research institutions and networks

Institutions

Pregistry

Prof Sonia Hernandez Diaz Harvard TH Chan School of Public Health, Boston, United States, Dr Diego Wyszynski Pregistry, Los Angeles. United States

Study timelines

Date when funding contract was signed

Actual: 01/02/2020

Study start date

Actual: 01/07/2020

Date of final study report

Actual: 01/01/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Johnson & Johnson, Regeneron

Study protocol

Initial protocol

IRCEP_Protocol_17Apr2020

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

https://corona.pregistry.com,ClinicalTrials.gov Identifier: NCT04366986