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| Name | Class |
|---|---|
| Harvard School of Public Health (HSPH) | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant Women | Women who are currently pregnant |
| |
| Post-partum women | Women who have been pregnant in the past 6 months |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tested for SARS-CoV-2 (regardless of the result) | Other | This is an observational study with no intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy outcomes | Miscarriage (or spontaneous abortion), Elective termination, Stillbirth, Preterm delivery | 1 year |
| Birth outcomes | Major structural defects, neonatal death, Admission into the Neonatal Intensive Care Unit, Maternal obstetric complications, Post-partum health | Birth to 90 days post-partum |
| Birth outcomes | Head circumference at birth in centimeters | Birth to 90 days post-partum |
| Birth outcomes | Length at birth in centimeters | Birth to 90 days post-partum |
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Inclusion Criteria:
Exclusion Criteria:
Persons assigned gender female at birth.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Diego Wyszynski, MD, MHS, PhD | CEO Pregistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pregistry | Los Angeles | California | 90045 | United States |
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| Label | URL |
|---|---|
| International Registry of Coronavirus (COVID-19) Exposure in Pregnancy | View source |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Clinical diagnosis of COVID-19 by a health care professional | Other | This is an observational study with no intervention |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |