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OpenTrials
Completed

NCT Number: NCT04444518

Increasing Influenza and Tdap Vaccination of Pregnant Women

Pregnant women who get influenza are more likely than non-pregnant women to have serious complications, including hospitalizations, death, preterm labor and premature birth. Pertussis can cause hospitalization or death for newborns. However, influenza and Tdap vaccination rates for pregnant women are low nationally. In this study, the investigators will perform a randomized controlled trial aimed at practice change in obstetricians' offices, with an overall goal of reducing morbidity and mortality from influenza and pertussis infections.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Medical Center (URMC)

Rochester, New York, 14642, United States

About this study

Infants under 6 months of age at increased risk of both influenza (flu) and pertussis disease, and pregnant women risk serious illness and premature labor from flu. The Advisory Committee on Immunization Practices recommends that women receive a flu vaccine in flu season, and tetanus toxoid, reduced diphtheria toxoid, acellular pertussis (Tdap) vaccine during each pregnancy (ideally between 27-36 weeks) to lower the risk for flu and pertussis disease for themselves and their infants. However, only half of pregnant women in the US receive a flu and Tdap vaccine, respectively; only 33% of women receive both vaccines. 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 flu and Tdap vaccination rates for pregnant women. To address these low vaccination rates 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 intervention and the other half to standard of care. The multi-component VAX-MOM 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

Patients

  • Sex is female
  • Pregnant
  • identified as being eligible for influenza or Tdap vaccine

Providers

  • any provider, nurse or staff associated with the participating sites

Exclusion criteria

Patients

  • none

Providers

  • none

Treatment and study plan

VAX-MOM Intervention

Behavioral

The multi-component VAX-MOM intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates.

Standard of Care

Behavioral

Standard vaccine education and processes provided to patients by obstetric practices.

Primary outcomes

  1. Rate of Influenza Vaccination

    Time frame: 10/1/2021-6/30/2022 (intervention flu season)

    Influenza vaccination rate during pregnancy. Vaccination status will be obtained from patient electronic health records.

  2. Rate of Tdap Vaccination

    Time frame: 7/1/2021 - 6/30/2022 (intervention period)

    Tdap vaccination rate during pregnancy. 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

Official study title

The VAX-MOM Study: Increasing Influenza and Tdap Vaccination of Pregnant Women

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 23, 2020
Registry last updated
Jan 10, 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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