University of Rochester Medical Center (URMC)
Rochester, New York, 14642, United States
NCT Number: NCT05570630
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.
Looking for future studies?
Notify MeFemale
Interventional
Not applicable
Rochester, New York, 14642, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patient criteria:
Practice personnel criteria:
*Provider, nurse or staff currently affiliated with (employed with) the participating OB/GYN sites
Exclusion criteria
*None
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 vaccine education and processes provided to patients by obstetric practices.
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.
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.
University of Rochester
Other
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.
Published trials that share one or more normalized conditions with this study.
NCT05168709
COVID-19, Coronaviridae Infections
Parkville, Victoria, Australia
View Trial DetailsNCT07128095
Behavior, Behavior, Animal
Bloomington, Indiana, United States
View Trial DetailsNCT04444518
Bacterial Infections, Bacterial Infections and Mycoses
Rochester, New York, United States
View Trial DetailsNCT05104385
COVID-19, COVID-19 Pandemic
Ankara, Turkey (Türkiye)
View Trial Details