COVID-19 PRIORITY (Pregnancy CoRonavIrus Outcomes RegIsTrY)

University of California San Francisco (UCSF)

Status: Completed

Conditions: COVID-19; Coronavirus; Pregnancy

Treatments: Other: Pregnant women under investigation for Coronavirus or diagnosed with COVID-19; Other: Postpartum women under investigation for Coronavirus or diagnosed with COVID-19

Study type: Observational

Funder types: Other

Identifiers

NCT04323839

20-30410

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,333 patients

Sex: Female

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,333 participants in 2 patient groups

Pregnant Women

Description:

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

Treatment:

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

Post-partum women

Description:

Women who have been pregnant in the past 6 weeks and are suspected or diagnosed COVID-19 positive.

Treatment:

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