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| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
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PRIORITY (Pregnancy CoRonavIrus Outcomes RegIsTrY) is a prospective cohort study of pregnant and recently pregnant women who are: either patients under investigation for COVID-19 or a confirmed case of COVID-19. Data from PRIORITY will be used to evaluate the impact of COVID-19 on the clinical course and pregnancy outcomes of pregnant women and women within 6 weeks of pregnancy.
The investigators will recruit women age 13 or older under investigation for COVID-19 or with confirmed COVID-19 at any clinical state across the United States. Eligible participants will be identified through voluntary physician referrals.
When an eligible patient is referred to the PRIORITY Coordinating Center at UCSF, a UCSF study coordinator will follow-up by phone with the patient and consent verbally. The participant will be asked to complete an approval to release medical information. The investigators will use patient questionnaires to assess symptoms, maternal clinical course, pregnancy outcomes, and neonatal outcomes from initial investigation of COVID-19 to 12 months. The investigators will also obtain all medical records for the participant to data abstract key clinical and pregnancy outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant Women | Women who are currently pregnant and are suspected or diagnosed COVID-19 positive. |
| |
| Post-partum women | Women who have been pregnant in the past 6 weeks and are suspected or diagnosed COVID-19 positive. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregnant women under investigation for Coronavirus or diagnosed with COVID-19 | Other | This is an observational study with no intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical presentation | presenting symptoms and testing | Baseline to 12 months |
| Disease prognosis outcomes | Clinical outcomes with resolution of illness | Baseline to 12 months |
| Pregnancy outcomes | Pregnancy outcomes among women infected with COVID-19 | Baseline to 12 months |
| Obstetric outcomes | Obstetric outcomes among women infected with COVID-19 | Baseline to 12 months |
| Neonatal outcomes | Neonatal outcomes among infants born to women with COVID-19 | Baseline to 12 months |
| Modes of transmission of COVID-19 | Transmission of COVID-19 from mother to infant | Baseline to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
1. <13 years of age.
Persons assigned gender female at birth.
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Pregnant women or women who have been pregnant in the last 6 weeks and are under investigation for COVID-19 or who have tested positive for COVID-19.
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| Name | Affiliation | Role |
|---|---|---|
| Vanessa Jacoby, MD, MAS | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33027186 | Derived | Afshar Y, Gaw SL, Flaherman VJ, Chambers BD, Krakow D, Berghella V, Shamshirsaz AA, Boatin AA, Aldrovandi G, Greiner A, Riley L, Boscardin WJ, Jamieson DJ, Jacoby VL; Pregnancy CoRonavIrus Outcomes RegIsTrY (PRIORITY) Study. Clinical Presentation of Coronavirus Disease 2019 (COVID-19) in Pregnant and Recently Pregnant People. Obstet Gynecol. 2020 Dec;136(6):1117-1125. doi: 10.1097/AOG.0000000000004178. |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| Postpartum women under investigation for Coronavirus or diagnosed with COVID-19 | Other | This is an observational study with no intervention |
|
| D007239 |
| Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |