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NCT Number: NCT04366986

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Pregistry

Los Angeles, California, 90045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tested for SARS-CoV-2 (regardless of the result)

Other

This is an observational study with no intervention

Clinical diagnosis of COVID-19 by a health care professional

Other

This is an observational study with no intervention

Primary outcomes

  1. Pregnancy outcomes

    Time frame: 1 year

    Miscarriage (or spontaneous abortion), Elective termination, Stillbirth, Preterm delivery

  2. Birth outcomes

    Time frame: Birth to 90 days post-partum

    Major structural defects, neonatal death, Admission into the Neonatal Intensive Care Unit, Maternal obstetric complications, Post-partum health

  3. Birth outcomes

    Time frame: Birth to 90 days post-partum

    Head circumference at birth in centimeters

  4. Birth outcomes

    Time frame: Birth to 90 days post-partum

    Length at birth in centimeters

Sponsors and collaborators

Lead sponsor

Pregistry

Industry

Collaborators

  • Harvard School of Public Health (HSPH)

Registry information

Official study title

International Registry of Coronavirus Exposure in Pregnancy (IRCEP)

Acronym: IRCEP

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 29, 2020
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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