Coronavirus, COVID-19, Pregnancy
Conditions
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.
Interventions
OTHERPregnant women under investigation for Coronavirus or diagnosed with COVID-19
This is an observational study with no intervention
OTHERPostpartum women under investigation for Coronavirus or diagnosed with COVID-19
This is an observational study with no intervention
Sponsors
University of California, Los Angeles
University of California, San Francisco
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
13 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal outcomes | Baseline to 12 months | Neonatal outcomes among infants born to women with COVID-19 |
| Modes of transmission of COVID-19 | Baseline to 12 months | Transmission of COVID-19 from mother to infant |
| Clinical presentation | Baseline to 12 months | presenting symptoms and testing |
| Disease prognosis outcomes | Baseline to 12 months | Clinical outcomes with resolution of illness |
| Pregnancy outcomes | Baseline to 12 months | Pregnancy outcomes among women infected with COVID-19 |
| Obstetric outcomes | Baseline to 12 months | Obstetric outcomes among women infected with COVID-19 |
Countries
United States
Outcome results
None listed