NCT05570630

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6,911 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Immunization; Infection
• Pregnancy Related
• COVID-19

Interventions

Type	Name	Description
BEHAVIORAL	VAX-MOM COVID-19 Intervention	The multi-component VAX-MOM COVID-19 intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates.
OTHER	Standard of Care	Standard vaccine education and processes provided to patients by obstetric practices.

Timeline

• Start date: 2022-10-21
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2022-10-06
• Last updated: 2025-09-04
• Results posted: 2025-09-04

Locations

1 site across 1 country: United States