NCT04323839

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,333

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2022

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

2.1 years

First QC Date

March 24, 2020

Last Update Submit

May 7, 2024

Conditions

PregnancyCoronavirusCOVID-19

Outcome Measures

Primary Outcomes (6)

  • Clinical presentation

    presenting symptoms and testing

    Baseline to 12 months

  • Disease prognosis outcomes

    Clinical outcomes with resolution of illness

    Baseline to 12 months

  • Pregnancy outcomes

    Pregnancy outcomes among women infected with COVID-19

    Baseline to 12 months

  • Obstetric outcomes

    Obstetric outcomes among women infected with COVID-19

    Baseline to 12 months

  • Neonatal outcomes

    Neonatal outcomes among infants born to women with COVID-19

    Baseline to 12 months

  • Modes of transmission of COVID-19

    Transmission of COVID-19 from mother to infant

    Baseline to 12 months

Study Arms (2)

Pregnant Women

Women who are currently pregnant and are suspected or diagnosed COVID-19 positive.

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.

Other: Postpartum women under investigation for Coronavirus or diagnosed with COVID-19

Interventions

Pregnant women under investigation for Coronavirus or diagnosed with COVID-19OTHER

This is an observational study with no intervention

Pregnant Women
Postpartum women under investigation for Coronavirus or diagnosed with COVID-19OTHER

This is an observational study with no intervention

Post-partum women

Eligibility Criteria

Age13 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPersons assigned gender female at birth.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • \. \<13 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (1)

  • 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.

    PMID: 33027186DERIVED

MeSH Terms

Conditions

Coronavirus InfectionsCOVID-19

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Vanessa Jacoby, MD, MAS

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2020

First Posted

March 27, 2020

Study Start

March 20, 2020

Primary Completion

April 26, 2022

Study Completion

April 26, 2022

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)