COVID-19 PRIORITY (Pregnancy CoRonavIrus Outcomes RegIsTrY)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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PRIORITY (Pregnancy Coronavirus Outcomes Registry)

Conditions
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Pregnancy, Coronavirus, COVID-19

Intervention / Treatment
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* Other: Pregnant women under investigation for Coronavirus or diagnosed with COVID-19
* Other: Postpartum women under investigation for Coronavirus or diagnosed with COVID-19


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women or women who have been pregnant within the last 6 weeks Able to give informed consent Diagnosed with COVID-19; or being evaluated for COVID-19 (patient under investigation) since January 1, 2020 Exclusion Criteria: 1. <13 years of age.

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant Women<br>Women who are currently pregnant and are suspected or diagnosed COVID-19 positive. | Other: Pregnant women under investigation for Coronavirus or diagnosed with COVID-19<br>* This is an observational study with no intervention<br>|
| Post-partum women<br>Women who have been pregnant in the past 6 weeks and are suspected or diagnosed COVID-19 positive. | Other: Postpartum women under investigation for Coronavirus or diagnosed with COVID-19<br>* This is an observational study with no intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |