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OpenTrials
Completed

NCT Number: NCT05570630

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

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Medical Center (URMC)

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Rate of COVID-19 Vaccination (6 Month)

    Time frame: 6 months

    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.

Secondary outcomes

  1. Rate of COVID-19 Vaccination (9 Month)

    Time frame: 9 months

    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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Centers for Disease Control and Prevention
  • University of California, Los Angeles

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 6, 2022
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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