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

Last updated: November 4, 2024
Sponsor: University of Rochester
Overall Status: Completed

Phase

N/A

Condition

Covid-19

Treatment

Standard of Care

VAX-MOM COVID-19 Intervention

Clinical Study ID

NCT05570630
STUDY00007624
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

*None

Study Design

Total Participants: 11279
Treatment Group(s): 2
Primary Treatment: Standard of Care
Phase:
Study Start date:
October 21, 2022
Estimated Completion Date:
July 31, 2024

Study 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.

Connect with a study center

  • Ronald Reagan

    Los Angeles, California 90095
    United States

    Site Not Available

  • Pasadena

    Pasadena, California 91105
    United States

    Site Not Available

  • Porter Ranch

    Porter Ranch, California 91326
    United States

    Site Not Available

  • Santa Monica

    Santa Monica, California 90404
    United States

    Site Not Available

  • South Bay: Torrance

    Torrance, California 90503
    United States

    Site Not Available

  • Westlake/Thousand Oaks

    Westlake Village, California 91361
    United States

    Site Not Available

  • Unity OB/GYN at Brockport

    Brockport, New York 14420
    United States

    Site Not Available

  • Clifton Springs Hospital & Clinic

    Clifton Springs, New York 14432
    United States

    Site Not Available

  • Finger Lakes Geneva

    Geneva, New York 14456
    United States

    Site Not Available

  • TWC Newark

    Newark, New York 14513
    United States

    Site Not Available

  • Community OB (COB)

    Rochester, New York 14609
    United States

    Site Not Available

  • Gender Wellness Obstetrics & Gynecology (GOG)

    Rochester, New York 14620
    United States

    Site Not Available

  • Highland Women's Health (HWH) (POB)

    Rochester, New York 14620
    United States

    Site Not Available

  • Park Ridge OBGYN

    Rochester, New York 14626
    United States

    Site Not Available

  • Parkway OBGYN

    Rochester, New York 14612
    United States

    Site Not Available

  • Strong Perinatal Associates (SPA)

    Rochester, New York 14623
    United States

    Site Not Available

  • TWC Clinton

    Rochester, New York 14605
    United States

    Site Not Available

  • TWC at Alexander Park

    Rochester, New York 14607
    United States

    Site Not Available

  • TWC at RGH (Portland)

    Rochester, New York 14621
    United States

    Site Not Available

  • UMG OBGYN Clinton Crossings

    Rochester, New York 14618
    United States

    Site Not Available

  • UMG OBGYN St Marys

    Rochester, New York 14611
    United States

    Site Not Available

  • URMC Midwifery at Culver

    Rochester, New York 14609
    United States

    Site Not Available

  • URMC Midwifery at Lattimore

    Rochester, New York 14620
    United States

    Site Not Available

  • Unity OB/GYN at Ridgeway

    Rochester, New York 14626
    United States

    Site Not Available

  • University OB/GYN (UOG)

    Rochester, New York 14620
    United States

    Site Not Available

  • University of Rochester Medical Center (URMC)

    Rochester, New York 14642
    United States

    Site Not Available

  • Bay Creek Midwifery

    Webster, New York 14580
    United States

    Site Not Available

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