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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 13 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

NCT ID
NCT04323839
Status
Completed
Sponsor
University of California, San Francisco

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.