Trial Outcomes & Findings for VAX-MOM COVID-19: Increasing Maternal COVID-19 Vaccination (NCT NCT05570630)
NCT ID: NCT05570630
Last Updated: 2025-09-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6911 participants
Primary outcome timeframe
6 months
Results posted on
2025-09-04
Participant Flow
Unit of analysis: Practices
Participant milestones
| Measure |
VAX-MOM COVID-19 Intervention
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.
|
Standard of Care
Standard of Care: Standard vaccine education and processes provided to patients by obstetric practices.
|
|---|---|---|
|
Overall Study
STARTED
|
4256 14
|
2655 11
|
|
Overall Study
COMPLETED
|
4256 14
|
2655 11
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Demographic data was not available for one health system
Baseline characteristics by cohort
| Measure |
VAX-MOM COVID-19 Intervention
n=4256 Participants
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.
|
Standard of Care
n=2655 Participants
Standard of Care: Standard vaccine education and processes provided to patients by obstetric practices.
|
Total
n=6911 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
43 Participants
n=1736 Participants • Demographic data was not available for one health system
|
39 Participants
n=1765 Participants • Demographic data was not available for one health system
|
82 Participants
n=3501 Participants • Demographic data was not available for one health system
|
|
Age, Categorical
Between 18 and 65 years
|
1693 Participants
n=1736 Participants • Demographic data was not available for one health system
|
1726 Participants
n=1765 Participants • Demographic data was not available for one health system
|
3419 Participants
n=3501 Participants • Demographic data was not available for one health system
|
|
Age, Categorical
>=65 years
|
0 Participants
n=1736 Participants • Demographic data was not available for one health system
|
0 Participants
n=1765 Participants • Demographic data was not available for one health system
|
0 Participants
n=3501 Participants • Demographic data was not available for one health system
|
|
Sex: Female, Male
Female
|
4256 Participants
n=4256 Participants
|
2655 Participants
n=2655 Participants
|
6911 Participants
n=6911 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=4256 Participants
|
0 Participants
n=2655 Participants
|
0 Participants
n=6911 Participants
|
|
Race/Ethnicity, Customized
Asian
|
47 Participants
n=1736 Participants • Data was missing from one health system
|
69 Participants
n=1765 Participants • Data was missing from one health system
|
116 Participants
n=3501 Participants • Data was missing from one health system
|
|
Race/Ethnicity, Customized
Black
|
319 Participants
n=1736 Participants • Data was missing from one health system
|
367 Participants
n=1765 Participants • Data was missing from one health system
|
686 Participants
n=3501 Participants • Data was missing from one health system
|
|
Race/Ethnicity, Customized
Hispanic
|
252 Participants
n=1736 Participants • Data was missing from one health system
|
265 Participants
n=1765 Participants • Data was missing from one health system
|
517 Participants
n=3501 Participants • Data was missing from one health system
|
|
Race/Ethnicity, Customized
White
|
931 Participants
n=1736 Participants • Data was missing from one health system
|
892 Participants
n=1765 Participants • Data was missing from one health system
|
1823 Participants
n=3501 Participants • Data was missing from one health system
|
|
Race/Ethnicity, Customized
Other/Unknown
|
187 Participants
n=1736 Participants • Data was missing from one health system
|
172 Participants
n=1765 Participants • Data was missing from one health system
|
359 Participants
n=3501 Participants • Data was missing from one health system
|
|
Region of Enrollment
United States
|
4256 participants
n=4256 Participants
|
2655 participants
n=2655 Participants
|
6911 participants
n=6911 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 6 month cohort
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.
Outcome measures
| Measure |
VAX-MOM COVID-19 Intervention
n=2789 Participants
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.
|
Standard of Care
n=1759 Participants
Standard of Care: Standard vaccine education and processes provided to patients by obstetric practices.
|
|---|---|---|
|
Rate of COVID-19 Vaccination (6 Month)
|
251 Participants
|
130 Participants
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: 9 month cohort
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.
Outcome measures
| Measure |
VAX-MOM COVID-19 Intervention
n=4256 Participants
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.
|
Standard of Care
n=2655 Participants
Standard of Care: Standard vaccine education and processes provided to patients by obstetric practices.
|
|---|---|---|
|
Rate of COVID-19 Vaccination (9 Month)
|
404 Participants
|
180 Participants
|
Adverse Events
VAX-MOM COVID-19 Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place