For Researchers

The PRIORITY study aims to address key questions on COVID-19 for pregnant or recently pregnant people and, as applicable, their newborns. This is a global disease pandemic and as such, we believe it is critical to be open and collaborative in all PRIORITY research activities. To that end, we will post publicly all data collection forms and the study protocol, including biospecimen collection protocols. Some of the data collection forms are currently in use and some we plan to introduce in the near future. If you do not see a form or protocol yet posted, please know that we are working to make these public as soon as possible.

Please note that we anticipate frequent updates to this site in the next few months as we expand our data collection elements and finalize outcome forms for distal endpoints (e.g. the 6 and 12 month Neonatal Outcome Forms). We will note changes to forms and place a date of posting on each.

PRIORITY opened for enrollment on March 22, 2020 for pregnant or recently pregnant people within the United States. Participant enrollment numbers are posted weekly on the home page https://priority.ucsf.edu/.

ClinicalTrials.gov Identifier: NCT04323839

Questions about information on this page? Email [email protected]

Click here for the PRIORITY Protocol

 

Patient-Reported Outcome Assessment: These forms are completed directly by the participant online, by phone, or through paper questionnaires.

Participants with Ongoing Pregnancy:  Schedule of Patient-Reported Outcome Assessment

 

Data Collection Form or Questionnaire

PUI/ COVID-19 Baseline

Once a week for 4 weeks

2nd Trimester GA 24 weeks

3rd Trimester GA 34 weeks

GA 38 weeks

GA 42 weeks

6 weeks postpartum

6 Months

12 Months

Demographics, Health History and COVID-19 Questions

X

 

 

 

 

 

 

 

 

COVID-19 Symptoms Follow-up

 

X

X

X

 

 

X

X

X

Pregnancy Status/Outcomes

 

X

X

X

X

X

X

 

 

Demographic Update             X    

Depression and Anxiety

  • Edinburgh Postnatal Depression Scale (EPDS)
  • Generalized Anxiety Disorder 7-item Scale (GAD-7)

X

 

X

X

 

 

X

X

X

Neonatal/Infant Outcomes

 

 

 

 

 

 

X

X

X

 

Participants with Pregnancy Completed: Schedule of Patient-Reported Outcome Assessment

 

Data Collection Form or Questionnaire

PUI/COVID-19 (Baseline)

Once a week for 4 weeks

Week 8

Month 6

Month 12

Demographics, Health History and COVID-19 Questions

X

 

 

 

 

Pregnancy Outcomes

X

 

 

 

 

COVID-19 Symptoms Follow-up

 

X

X

X

X

Demographic Update     X    

Depression and Anxiety

  • Edinburgh Postnatal Depression Scale (EPDS)
  • Generalized Anxiety Disorder 7-item Scale (GAD-7)

X

 

X

X

X

Neonatal/Infant Outcomes

X

 

X

X

X

 

Patient-Reported Outcomes, Data Collection Forms:

 

Medical Record Data Abstraction Forms:

  • Maternal Outcomes

  • Neonatal/Infant Outcomes