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NCT05570630 Clinical Trial

VAX-MOM COVID-19: Increasing Maternal COVID-19 Vaccination

COVID-19 Clinical Trial

Official title:
VAX-MOM COVID-19: Increasing Maternal COVID-19 Vaccination

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05570630
Other study ID # STUDY00007624
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date October 21, 2022
Est. completion date July 2024

Study information
Verified date August 2023
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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-19 vaccination rates for pregnant people overall. Lack of vaccination stems from a combination of patient (lack of knowledge, vaccine hesitancy), provider (suboptimal communication skills, missed opportunities), and system (e.g. lack of standing orders and patient reminders) factors. An effective intervention is needed to improve COVID-19 vaccination rates for pregnant people. To address this, the investigators plan to use a clustered RCT (randomizing practices), allocating half of the participating practice sites within each health system to the VAX-MOM COVID-19 intervention and the other half to standard of care. The multi-component VAX-MOM COVID-19 intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• VAX-MOM COVID-19 Intervention
The multi-component VAX-MOM COVID-19 intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates.
Other:
• Standard of Care
Standard vaccine education and processes provided to patients by obstetric practices.

Locations
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

Sponsors (3)
Lead Sponsor Collaborator
University of Rochester Centers for Disease Control and Prevention, University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome
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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