COVID-19 PRIORITY (Pregnancy CoRonavIrus Outcomes RegIsTrY)

Completed

• Conditions: Coronavirus; Pregnancy; COVID-19
• Interventions: Other: Postpartum women under investigation for Coronavirus or diagnosed with COVID-19; Other: Pregnant women under investigation for Coronavirus or diagnosed with COVID-19

• Registration Number: NCT04323839
• Lead Sponsor: University of California, San Francisco

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.

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 Timeline

• Study Start: 2020-03-20
• Study First Submitted: 2020-03-24
• Study First Submitted QC: 2020-03-24
• Study First Posted: 2020-03-27
• Primary Completion: 2022-04-26
• Study Completion: 2022-04-26
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1333

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

Read More

Exclusion Criteria

1. <13 years of age.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-partum women	Postpartum women under investigation for Coronavirus or diagnosed with COVID-19	Women who have been pregnant in the past 6 weeks and are suspected or diagnosed COVID-19 positive.
Pregnant Women	Pregnant women under investigation for Coronavirus or diagnosed with COVID-19	Women who are currently pregnant and are suspected or diagnosed COVID-19 positive.

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States