COVID-19 PRIORITY (Pregnancy CoRonavIrus Outcomes RegIsTrY) (PRIORITY)
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ClinicalTrials.gov Identifier: NCT04323839 |
Recruitment Status :
Active, not recruiting
First Posted : March 27, 2020
Last Update Posted : November 11, 2021
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Condition or disease | Intervention/treatment |
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Pregnancy Coronavirus COVID-19 | Other: Pregnant women under investigation for Coronavirus or diagnosed with COVID-19 Other: Postpartum women under investigation for Coronavirus or diagnosed with COVID-19 |
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.
Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 1333 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 12 Months |
Official Title: | PRIORITY (Pregnancy Coronavirus Outcomes Registry) |
Actual Study Start Date : | March 20, 2020 |
Estimated Primary Completion Date : | March 31, 2024 |
Estimated Study Completion Date : | March 31, 2024 |

Group/Cohort | Intervention/treatment |
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Pregnant Women
Women who are currently pregnant and are suspected or diagnosed COVID-19 positive.
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Other: Pregnant women under investigation for Coronavirus or diagnosed with COVID-19
This is an observational study with no intervention |
Post-partum women
Women who have been pregnant in the past 6 weeks and are suspected or diagnosed COVID-19 positive.
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Other: Postpartum women under investigation for Coronavirus or diagnosed with COVID-19
This is an observational study with no intervention |
- Clinical presentation [ Time Frame: Baseline to 12 months ]presenting symptoms and testing
- Disease prognosis outcomes [ Time Frame: Baseline to 12 months ]Clinical outcomes with resolution of illness
- Pregnancy outcomes [ Time Frame: Baseline to 12 months ]Pregnancy outcomes among women infected with COVID-19
- Obstetric outcomes [ Time Frame: Baseline to 12 months ]Obstetric outcomes among women infected with COVID-19
- Neonatal outcomes [ Time Frame: Baseline to 12 months ]Neonatal outcomes among infants born to women with COVID-19
- Modes of transmission of COVID-19 [ Time Frame: Baseline to 12 months ]Transmission of COVID-19 from mother to infant

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.
Ages Eligible for Study: | 13 Years and older (Child, 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 |
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.

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): NCT04323839
United States, California | |
University of California, San Francisco | |
San Francisco, California, United States, 94143 |
Principal Investigator: | Vanessa Jacoby, MD, MAS | University of California, San Francisco |
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT04323839 |
Other Study ID Numbers: |
20-30410 |
First Posted: | March 27, 2020 Key Record Dates |
Last Update Posted: | November 11, 2021 |
Last Verified: | November 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Coronavirus Infections Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia |
Virus Diseases Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |