VAX-MOM COVID-19: Increasing Maternal COVID-19 Vaccination
Part of paid clinical trials in Rochester, New York.
- Sponsor
- University of Rochester
- Study ID
- NCT05570630
- Status
- Completed
Conditions
- COVID-19
- Immunization; Infection
- Pregnancy Related
Eligibility Criteria
- Sex
- FEMALE
- Age
- N/A - N/A
- Healthy Volunteers
- Accepted
Interventions
- VAX-MOM COVID-19 Intervention — BEHAVIORALThe multi-component VAX-MOM COVID-19 intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates.
- Standard of Care — OTHERStandard vaccine education and processes provided to patients by obstetric practices.
Study Details
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.
Key Dates
- Start date
- Oct 21, 2022
- Status verified
- Aug 2025
- Primary completion
- Jul 31, 2024
- Completion
- Jul 31, 2024
Study Design
- Enrollment
- 6,911 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Experimental: VAX-MOM COVID-19 Intervention
- Active Comparator: Standard of Care
Primary Outcome Measure
Rate of COVID-19 Vaccination (6 Month) [ Time Frame: 6 months ]
Locations (1)
| Facility | City | State | ZIP |
|---|---|---|---|
| University of Rochester Medical Center (URMC) | Rochester | New York | 14642 |
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