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

NCT05570630 | Completed Results

• 1 other identifier: STUDY00007624
• Study Type: interventional
• Target: 6,911
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Immunization; Infection; Pregnancy Related; COVID-19

Keywords

COVID-19; Vaccination; Prenatal Care

Outcome Measures

Primary Outcomes (1)

• Rate of COVID-19 Vaccination (6 Month)

  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.

  6 months

Secondary Outcomes (1)

• Rate of COVID-19 Vaccination (9 Month)

  9 months

Study Arms (2)

VAX-MOM COVID-19 Intervention

EXPERIMENTAL

Behavioral: VAX-MOM COVID-19 Intervention

Standard of Care

ACTIVE COMPARATOR

Other: Standard of Care

Interventions

VAX-MOM COVID-19 Intervention BEHAVIORAL

The multi-component VAX-MOM COVID-19 intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates.

VAX-MOM COVID-19 Intervention

Standard of Care OTHER

Standard vaccine education and processes provided to patients by obstetric practices.

Standard of Care

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \*None

Sponsors & Collaborators

• University of Rochester: lead
• Centers for Disease Control and Prevention: collaborator
• University of California, Los Angeles: collaborator

Study Sites (1)

University of Rochester Medical Center (URMC)

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Infections; COVID-19

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Cynthia Rand, PI
• Organization: University of Rochester

cynthia_rand@urmc.rochester.edu

5852759316

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 6, 2022
• Study Start: October 21, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: September 4, 2025
• Results First Posted: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)