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

PRIORITY (Pregnancy Coronavirus Outcomes Registry)

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Pregnancy; Coronavirus
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 1333

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: University of California, Los Angeles
• Investigators: Principal Investigator: Vanessa Jacoby, MD, MAS, University of California, San Francisco

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2020
• Primary Completion (Actual): April 26, 2022
• Study Completion (Actual): April 26, 2022

Study Registration Dates

• First Submitted: March 24, 2020
• First Submitted That Met QC Criteria: March 24, 2020
• First Posted (Actual): March 27, 2020

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections
• Other Study ID Numbers: 20-30410

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No