COVID-19 PRIORITY (Pregnancy CoRonavIrus Outcomes RegIsTrY)

COVID-19 Clinical Trial

— PRIORITY  

Official title:

PRIORITY (Pregnancy Coronavirus Outcomes Registry)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04323839
• Other study ID #: 20-30410
• Status: Completed
• Start date: March 20, 2020
• Est. completion date: April 26, 2022

Study information

• Verified date: May 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1333
• Est. completion date: April 26, 2022
• Est. primary completion date: April 26, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections
• COVID-19
• Pregnancy

Intervention

Other:
• Pregnant women under investigation for Coronavirus or diagnosed with COVID-19
This is an observational study with no intervention
• Postpartum women under investigation for Coronavirus or diagnosed with COVID-19
This is an observational study with no intervention

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical presentation	presenting symptoms and testing	Baseline to 12 months
Primary	Disease prognosis outcomes	Clinical outcomes with resolution of illness	Baseline to 12 months
Primary	Pregnancy outcomes	Pregnancy outcomes among women infected with COVID-19	Baseline to 12 months
Primary	Obstetric outcomes	Obstetric outcomes among women infected with COVID-19	Baseline to 12 months
Primary	Neonatal outcomes	Neonatal outcomes among infants born to women with COVID-19	Baseline to 12 months
Primary	Modes of transmission of COVID-19	Transmission of COVID-19 from mother to infant	Baseline to 12 months