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

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ClinicalTrials.gov Identifier: NCT04366986
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : June 25, 2020
Sponsor:
Collaborator:
Harvard School of Public Health
Information provided by (Responsible Party):
Pregistry

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 25000 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
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : April 30, 2024

Resource links provided by the National Library of Medicine


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




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



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

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


Contacts
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Contact: Diego Wyszynski, MD, MHS, PhD (747) 200-5468 IRCEP@pregistry.com
Contact: Sonia Hernandez-Diaz, MD, DrPH (747) 200-5468 IRCEP@pregistry.com

Locations
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United States, California
Pregistry Recruiting
Los Angeles, California, United States, 90045
Contact: Diego Wyszynski, MD, MHS, PhD         
Sub-Investigator: Sonia Hernandez-Diaz, MD, DrPH         
Sponsors and Collaborators
Pregistry
Harvard School of Public Health
Investigators
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Principal Investigator: Diego Wyszynski, MD, MHS, PhD CEO Pregistry
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: June 25, 2020
Last Verified: June 2020
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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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases