Clinical trial NCT04323839: COVID-19 PRIORITY (Pregnancy CoRonavIrus Outcomes RegIsTrY)
Official title: PRIORITY (Pregnancy Coronavirus Outcomes Registry)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Coronavirus
COVID-19
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
First posted: 2020-03-27
Enrollment: 1333
Sex: FEMALE
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women or women who have been pregnant in the last 6 weeks and are under investigation for COVID-19 or who have tested positive for COVID-19.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical presentation
timeFrame: Baseline to 12 months
measure: Disease prognosis outcomes
timeFrame: Baseline to 12 months
measure: Pregnancy outcomes
timeFrame: Baseline to 12 months
measure: Obstetric outcomes
timeFrame: Baseline to 12 months
measure: Neonatal outcomes
timeFrame: Baseline to 12 months
measure: Modes of transmission of COVID-19
timeFrame: Baseline to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Vanessa Jacoby, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.