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
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 |
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| COVID-19 Symptoms Follow-up |
| X | X | X |
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| X | X | X |
| Pregnancy Status/Outcomes |
| X | X | X | X | X | X |
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| Demographic Update | X | ||||||||
| Food Insecurity | X | X | X | ||||||
| RHEBJ QoL/Discrimination Form | X | X | X | ||||||
| 6 Month Form | X | ||||||||
| 6 and 12 Month Form | X | X | |||||||
| 12 Month Breastfeeding Form | X | ||||||||
Depression and Anxiety
| X |
| X | X |
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| X | X | X |
| Neonatal/Infant Outcomes |
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| 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 |
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| Pregnancy Outcomes | X |
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| COVID-19 Symptoms Follow-up |
| X | X | X | X |
| Demographic Update | X | ||||
| Food Insecurity | X | X | X | ||
| RHEBJ QoL/Discrimination Form | X | X | X | ||
| 6 Month Form | X | X | |||
| 6 and 12 Month Form | X | X | |||
| 12 Month Breastfeeding Form | X | ||||
Depression and Anxiety
| X |
| X | X | X |
| Neonatal/Infant Outcomes | X |
| X | X | X |
Patient-Reported Outcomes, Data Collection Forms:
Demographics Form
Health History and COVID-19 Questions
Pregnancy and Neonatal Outcomes Form
COVID-19 Symptoms Follow-up Form
Neonatal 6 week/8 week follow up Form
Neonatal 6 month/12 month follow-up Form
Demographic Update form
Food Insecurity 6/8 Week form
Food Insecurity 6/12 Month form
RHEBJ 6 week/6 month/12 month form
PRIORITY 6 Month form
PRIORITY 6 and 12 Month form
12 Month Breastfeeding form
Edinburgh Postnatal Depression Scale (EPDS)
Generalized Anxiety Disorder 7-item Scale (GAD-7)
Medical Record Data Abstraction Forms:
Maternal Outcomes
Neonatal/Infant Outcomes