COVID-19 PRIORITY (Pregnancy CoRonavIrus Outcomes RegIsTrY)

Sponsor

University of California, San Francisco (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04323839

Collaborator

University of California, Los Angeles (Other)

1,333

Enrollment

Location

48.4

Anticipated Duration (Months)

27.6

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

Study Type:

Observational [Patient Registry]

Actual Enrollment :

1333 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

PRIORITY (Pregnancy Coronavirus Outcomes Registry)

Actual Study Start Date :

Mar 20, 2020

Anticipated Primary Completion Date :

Mar 31, 2024

Anticipated Study Completion Date :

Mar 31, 2024

Arms and Interventions

Arm	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

Arm

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

Primary Outcome Measures

Clinical presentation [Baseline to 12 months]
presenting symptoms and testing
Disease prognosis outcomes [Baseline to 12 months]
Clinical outcomes with resolution of illness
Pregnancy outcomes [Baseline to 12 months]
Pregnancy outcomes among women infected with COVID-19
Obstetric outcomes [Baseline to 12 months]
Obstetric outcomes among women infected with COVID-19
Neonatal outcomes [Baseline to 12 months]
Neonatal outcomes among infants born to women with COVID-19
Modes of transmission of COVID-19 [Baseline to 12 months]
Transmission of COVID-19 from mother to infant

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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:

<13 years of age.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Principal Investigator: Vanessa Jacoby, MD, MAS, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT04323839

Other Study ID Numbers:

20-30410

First Posted:

Mar 27, 2020

Last Update Posted:

Nov 11, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Coronavirus Infections

Study Results

No Results Posted as of Nov 11, 2021