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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04366986
Recruitment Status : Completed
First Posted : April 29, 2020
Last Update Posted : September 28, 2021
Sponsor:
Collaborator:
Harvard School of Public Health (HSPH)
Information provided by (Responsible Party):
Pregistry

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Covid-19 Other: Tested for SARS-CoV-2 (regardless of the result) Other: Clinical diagnosis of COVID-19 by a health care professional

Detailed 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.

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 17318 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: International Registry of Coronavirus Exposure in Pregnancy (IRCEP)
Actual Study Start Date : June 23, 2020
Actual Primary Completion Date : August 31, 2021
Actual Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Pregnant Women
Women who are currently pregnant
 Other: Tested for SARS-CoV-2 (regardless of the result)
This is an observational study with no intervention

Other: Clinical diagnosis of COVID-19 by a health care professional
This is an observational study with no intervention
Post-partum women
Women who have been pregnant in the past 6 months
 Other: Tested for SARS-CoV-2 (regardless of the result)
This is an observational study with no intervention

Other: Clinical diagnosis of COVID-19 by a health care professional
This is an observational study with no intervention


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Persons assigned gender female at birth.
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women, or women who have been pregnant in the last 6 months, who were tested for SARS-CoV-2 (regardless of the result) or were clinically diagnosed with COVID-19 by a health care professional.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04366986


Locations
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United States, California
Pregistry
Los Angeles, California, United States, 90045
Sponsors and Collaborators
Pregistry
Harvard School of Public Health (HSPH)
Investigators
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Principal Investigator: Diego Wyszynski, MD, MHS, PhD CEO Pregistry
More Information
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Additional Information:

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Responsible Party: Pregistry
ClinicalTrials.gov Identifier: NCT04366986    
Other Study ID Numbers: 0001
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases