COVID-19 Clinical Trial
Official title:
VAX-MOM COVID-19: Increasing Maternal COVID-19 Vaccination
Verified date | August 2023 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
COVID-19 infection during pregnancy is associated with increased risk of pre-eclampsia, preterm birth and stillbirth. Pregnant people with COVID-19 have a higher rate of ICU admission and intubation than those who are not pregnant. COVID-19 vaccine is recommended before pregnancy and during pregnancy to decrease these risks. Despite the benefits of COVID-19 vaccination, only 71% of pregnant women were vaccinated for COVID-19 as of June 2022 (most prior to pregnancy), with a much lower rate of 58% among non-Hispanic Black women. An effective intervention is needed to improve COVID vaccination rates for pregnant people overall. In this study, the investigators will perform a randomized controlled trial aimed at practice change in obstetricians' offices, with an overall goal of increasing maternal COVID-19 vaccination rates.
Status | Enrolling by invitation |
Enrollment | 8000 |
Est. completion date | July 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: Patient criteria: - Sex is female - Pregnant - Identified as being eligible for COVID-19 vaccine Practice personnel criteria: *Provider, nurse or staff currently affiliated with (employed with) the participating OB/GYN sites Exclusion Criteria: *None |
Country | Name | City | State |
---|---|---|---|
United States | Unity OB/GYN at Brockport | Brockport | New York |
United States | Clifton Springs Hospital & Clinic | Clifton Springs | New York |
United States | Finger Lakes Geneva | Geneva | New York |
United States | Ronald Reagan | Los Angeles | California |
United States | TWC Newark | Newark | New York |
United States | Pasadena | Pasadena | California |
United States | Porter Ranch | Porter Ranch | California |
United States | Community OB (COB) | Rochester | New York |
United States | Gender Wellness Obstetrics & Gynecology (GOG) | Rochester | New York |
United States | Highland Women's Health (HWH) (POB) | Rochester | New York |
United States | Park Ridge OBGYN | Rochester | New York |
United States | Parkway OBGYN | Rochester | New York |
United States | Strong Perinatal Associates (SPA) | Rochester | New York |
United States | TWC at Alexander Park | Rochester | New York |
United States | TWC at RGH (Portland) | Rochester | New York |
United States | TWC Clinton | Rochester | New York |
United States | UMG OBGYN Clinton Crossings | Rochester | New York |
United States | UMG OBGYN St Marys | Rochester | New York |
United States | Unity OB/GYN at Ridgeway | Rochester | New York |
United States | University OB/GYN (UOG) | Rochester | New York |
United States | URMC Midwifery at Culver | Rochester | New York |
United States | URMC Midwifery at Lattimore | Rochester | New York |
United States | Santa Monica | Santa Monica | California |
United States | South Bay: Torrance | Torrance | California |
United States | Bay Creek Midwifery | Webster | New York |
United States | Westlake/Thousand Oaks | Westlake Village | California |
Lead Sponsor | Collaborator |
---|---|
University of Rochester | Centers for Disease Control and Prevention, University of California, Los Angeles |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of COVID-19 vaccination | Average rate of COVID-19 vaccination will be compared between intervention and control arms, for vaccine eligible patients at participating OB/GYN practice sites. Vaccination status will be obtained from patient electronic health records. | 6 month baseline compared to 6 month intervention |
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