PregnancyPRIORITYNCT04323839
COVID-19 PRIORITY (Pregnancy CoRonavIrus Outcomes RegIsTrY)
An observational study of Pregnancy and Coronavirus, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older, women only
- Conditions the study is for
- Pregnancy, Coronavirus, COVID-19
- What is being tested?
- Pregnant women under investigation for Coronavirus or diagnosed with COVID-19 and Postpartum women under investigation for Coronavirus or diagnosed with COVID-19
- How many people
- 1,333 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2020to 26 Apr 2022
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Pregnant women or women who have been pregnant within the last 6 weeks
- Able to give informed consent
- Diagnosed with COVID-19; or being evaluated for COVID-19 ("patient under investigation") since January 1, 2020
Who cannot join
- 1. <13 years of age.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: PRIORITY (Pregnancy Coronavirus Outcomes Registry)
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.
Read the 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.
- Conditions
- Pregnancy, Coronavirus, COVID-19
- Being tested
- Pregnant women under investigation for Coronavirus or diagnosed with COVID-19, Postpartum women under investigation for Coronavirus or diagnosed with COVID-19
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnant women under investigation for Coronavirus or diagnosed with COVID-19Other
This is an observational study with no intervention
Postpartum women under investigation for Coronavirus or diagnosed with COVID-19Other
This is an observational study with no intervention
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Women | Women who are currently pregnant and are suspected or diagnosed COVID-19 positive. Receives: Other: Pregnant women under investigation for Coronavirus or diagnosed with COVID-19 | |
| Post-partum women | Women who have been pregnant in the past 6 weeks and are suspected or diagnosed COVID-19 positive. Receives: Other: Postpartum women under investigation for Coronavirus or diagnosed with COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical presentation
presenting symptoms and testing
Measured: Baseline to 12 months
Disease prognosis outcomes
Clinical outcomes with resolution of illness
Measured: Baseline to 12 months
Pregnancy outcomes
Pregnancy outcomes among women infected with COVID-19
Measured: Baseline to 12 months
Obstetric outcomes
Obstetric outcomes among women infected with COVID-19
Measured: Baseline to 12 months
Neonatal outcomes
Neonatal outcomes among infants born to women with COVID-19
Measured: Baseline to 12 months
Modes of transmission of COVID-19
Transmission of COVID-19 from mother to infant
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start20 Mar 2020
- Primary completion26 Apr 2022
- Study completion26 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,333 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Vanessa Jacoby, MD, MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323839
- Sponsor's protocol ID
- 20-30410
- Acronym
- PRIORITY
- Status last verified
- May 2024
- First submitted
- 24 Mar 2020
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33027186
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRIORITY (Pregnancy Coronavirus Outcomes Registry)
- ClinicalTrials.gov ID
- NCT04323839
- Acronym / sponsor ID
- PRIORITY / 20-30410
- Conditions
- Pregnancy, Coronavirus, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,333 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 26 Apr 2022 (actual)
- Study completion
- 26 Apr 2022 (actual)
- First posted
- 27 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women | – | Other: Pregnant women under investigation for Coronavirus or diagnosed with COVID-19Women who are currently pregnant and are suspected or diagnosed COVID-19 positive. |
| Post-partum women | – | Other: Postpartum women under investigation for Coronavirus or diagnosed with COVID-19Women who have been pregnant in the past 6 weeks and are suspected or diagnosed COVID-19 positive. |
Who may qualify
- Ages
- 13 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Pregnant women or women who have been pregnant within the last 6 weeks
- Able to give informed consent
- Diagnosed with COVID-19; or being evaluated for COVID-19 ("patient under investigation") since January 1, 2020
Key exclusion criteria (1 listed)
- 1. <13 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pregnant women under investigation for Coronavirus or diagnosed with COVID-19This is an observational study with no intervention | Other | Pregnant Women |
| Postpartum women under investigation for Coronavirus or diagnosed with COVID-19This is an observational study with no intervention | Other | Post-partum women |
Primary outcome
Clinical presentation
Time frame: Baseline to 12 months
presenting symptoms and testing
Disease prognosis outcomes
Time frame: Baseline to 12 months
Clinical outcomes with resolution of illness
Pregnancy outcomes
Time frame: Baseline to 12 months
Pregnancy outcomes among women infected with COVID-19
Obstetric outcomes
Time frame: Baseline to 12 months
Obstetric outcomes among women infected with COVID-19
Neonatal outcomes
Time frame: Baseline to 12 months
Neonatal outcomes among infants born to women with COVID-19
Modes of transmission of COVID-19
Time frame: Baseline to 12 months
Transmission of COVID-19 from mother to infant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Derived from this study: PubMed 33027186Afshar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanessa Jacoby, MD, MAS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Coronavirus, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical presentation (time frame: Baseline to 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04323839, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.