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 — BEHAVIORAL
    The 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 — OTHER
    Standard 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)

FacilityCityStateZIP
University of Rochester Medical Center (URMC)RochesterNew York14642

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