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Completed

NCT Number: NCT04323839

COVID-19 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.

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Key information

Conditions

Pregnancy COVID-19 Coronaviridae Infections Coronavirus Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

13 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

This is an observational study with no intervention

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

Other

This is an observational study with no intervention

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • University of California, Los Angeles

Registry information

Official study title

PRIORITY (Pregnancy Coronavirus Outcomes Registry)

Acronym: PRIORITY

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 27, 2020
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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