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COVID-19 PRIORITY (Pregnancy CoRonavIrus Outcomes RegIsTrY) (PRIORITY)

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ClinicalTrials.gov Identifier: NCT04323839
Recruitment Status : Enrolling by invitation
First Posted : March 27, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
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

Detailed Description:

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Pregnant Women
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
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.
 Other: Postpartum women under investigation for Coronavirus or diagnosed with COVID-19
This is an observational study with no intervention


Outcome Measures
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Primary Outcome Measures :
  1. Clinical presentation [ Time Frame: Baseline to 12 months ]
    presenting symptoms and testing

  2. Disease prognosis outcomes [ Time Frame: Baseline to 12 months ]
    Clinical outcomes with resolution of illness

  3. Pregnancy outcomes [ Time Frame: Baseline to 12 months ]
    Pregnancy outcomes among women infected with COVID-19

  4. Obstetric outcomes [ Time Frame: Baseline to 12 months ]
    Obstetric outcomes among women infected with COVID-19

  5. Neonatal outcomes [ Time Frame: Baseline to 12 months ]
    Neonatal outcomes among infants born to women with COVID-19

  6. Modes of transmission of COVID-19 [ Time Frame: Baseline to 12 months ]
    Transmission of COVID-19 from mother to infant


Eligibility Criteria
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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:   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
Study Population
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.
Criteria

Inclusion Criteria:

  1. Pregnant women or women who have been pregnant within the last 6 weeks
  2. Able to give informed consent
  3. Diagnosed with COVID-19; or being evaluated for COVID-19 ("patient under investigation") since January 1, 2020

Exclusion Criteria:

1. <13 years of age.

Contacts and Locations
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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): NCT04323839


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
University of California, Los Angeles
Investigators
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Principal Investigator: Vanessa Jacoby, MD, MAS University of California, San Francisco
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: October 19, 2020
Last Verified: October 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