NCT04444518

Increasing Influenza and Tdap Vaccination of Pregnant Women

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12,760 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Immunization; Infection
• Pregnancy Related

Interventions

Type	Name	Description
BEHAVIORAL	VAX-MOM Intervention	The multi-component VAX-MOM intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates.
BEHAVIORAL	Standard of Care	Standard vaccine education and processes provided to patients by obstetric practices.

Timeline

• Start date: 2019-07-01
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2020-06-23
• Last updated: 2025-01-10
• Results posted: 2025-01-10

Locations

1 site across 1 country: United States