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International Registry of Coronavirus (COVID-19) Exposure in Pregnancy (IRCEP)

P

Pregistry

Status

Completed

Conditions

Covid-19

Treatments

Other: Clinical diagnosis of COVID-19 by a health care professional
Other: Tested for SARS-CoV-2 (regardless of the result)

Study type

Observational

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

The International Registry of Coronavirus Exposure in Pregnancy (IRCEP) is a prospective cohort study of pregnant and recently pregnant women who have been tested for SARS-CoV-2 (regardless of the result) or have been clinically diagnosed with COVID-19 by a health care professional. Data from the IRCEP will be used to evaluate the impact of COVID-19 on pregnancy and birth outcomes.

Full description

The International Registry of Coronavirus Exposure in Pregnancy (IRCEP) will enroll women 18 years of age and older who are currently pregnant or have been pregnant women within the last 6 months, and who have been tested for SARS-CoV-2 (regardless of the result) or have been clinically diagnosed with COVID-19 by a health care professional. As this is an international registry, women from all countries are welcome to participate.

Women will enroll and provide information to the IRCEP via website and mobile app. After signing the electronic informed consent document, registrants will answer questions on the following modules: Demographics, Reproductive History, Height and Weight, Habits, Health Conditions, Medications, Current Pregnancy, COVID-19 Infection Test, and COVID-19 Infection Symptoms. Monthly follow-up modules will continue until the pregnancy outcome. In case of a live birth, the Registry participant will continue with the Post-Partum Outcomes module until the newborn is 90 days of age. Medical records from the mother and neonate will also be requested.

Enrollment

17,318 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Pregnant women or women who have been pregnant within the last 6 months
  • Able to give electronic informed consent
  • Tested for SARS-CoV-2 (regardless of the result) or clinically diagnosed with COVID-19 by a health care professional

Exclusion criteria

  • <18 years of age

Trial design

17,318 participants in 2 patient groups

Pregnant Women
Description:
Women who are currently pregnant
Treatment:
Other: Clinical diagnosis of COVID-19 by a health care professional
Other: Tested for SARS-CoV-2 (regardless of the result)
Post-partum women
Description:
Women who have been pregnant in the past 6 months
Treatment:
Other: Clinical diagnosis of COVID-19 by a health care professional
Other: Tested for SARS-CoV-2 (regardless of the result)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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