COVID-19 PRIORITY (Pregnancy CoRonavIrus Outcomes RegIsTrY)

NCT ID: NCT04323839

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1333 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-20

Study Completion Date

2022-04-26

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pregnancy Coronavirus COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant Women

Women who are currently pregnant and are suspected or diagnosed COVID-19 positive.

Pregnant women under investigation for Coronavirus or diagnosed with COVID-19

Intervention Type OTHER

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.

Postpartum women under investigation for Coronavirus or diagnosed with COVID-19

Intervention Type OTHER

This is an observational study with no intervention

Interventions

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Pregnant women under investigation for Coronavirus or diagnosed with COVID-19

This is an observational study with no intervention

Intervention Type OTHER

Postpartum women under investigation for Coronavirus or diagnosed with COVID-19

This is an observational study with no intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vanessa Jacoby, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33027186 (View on PubMed)

Other Identifiers

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20-30410

Identifier Type: -

Identifier Source: org_study_id

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