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

NCT ID: NCT04366986

Last Updated: 2021-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17318 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-23

Study Completion Date

2021-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Covid-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant Women

Women who are currently pregnant

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

Intervention Type OTHER

This is an observational study with no intervention

Clinical diagnosis of COVID-19 by a health care professional

Intervention Type OTHER

This is an observational study with no intervention

Post-partum women

Women who have been pregnant in the past 6 months

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

Intervention Type OTHER

This is an observational study with no intervention

Clinical diagnosis of COVID-19 by a health care professional

Intervention Type OTHER

This is an observational study with no intervention

Interventions

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

This is an observational study with no intervention

Intervention Type OTHER

Clinical diagnosis of COVID-19 by a health care professional

This is an observational study with no intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Harvard School of Public Health (HSPH)

OTHER

Sponsor Role collaborator

Pregistry

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Diego Wyszynski, MD, MHS, PhD

Role: PRINCIPAL_INVESTIGATOR

CEO Pregistry

Locations

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Pregistry

Los Angeles, California, United States

Site Status

Countries

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United States

Related Links

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https://ircep.pregistry.com

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

Other Identifiers

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0001

Identifier Type: -

Identifier Source: org_study_id

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