N/A
N=6,911
VAX-MOM COVID-19: Increasing Maternal COVID-19 Vaccination
Immunization; Infection · Pregnancy Related · COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT05570630 ↗Enrolled (actual)
6,911
Serious AEs
—
Results posted
Sep 2025
Primary outcome: Primary: Rate of COVID-19 Vaccination (6 Month) — 251; 130 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- VAX-MOM COVID-19 Intervention (Behavioral); Standard of Care (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- University of Rochester
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of COVID-19 Vaccination (6 Month) |
251; 130 | — |
| SECONDARY Rate of COVID-19 Vaccination (9 Month) |
404; 180 | — |
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.
Eligibility Criteria
Inclusion Criteria
Patient criteria:
- Sex is female
- Pregnant
- Identified as being eligible for COVID-19 vaccine
Practice personnel criteria:
*Provider, nurse or staff currently affiliated with (employed with) the participating OB/GYN sites
Exclusion Criteria
*None
Data sourced from ClinicalTrials.gov (NCT05570630). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.