search
Back to results

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

Primary Purpose

Immunization; Infection, Pregnancy Related, COVID-19

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VAX-MOM COVID-19 Intervention
Standard of Care
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Immunization; Infection focused on measuring COVID-19, Vaccination, Prenatal Care

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ronald Reagan
  • Pasadena
  • Porter Ranch
  • Santa Monica
  • South Bay: Torrance
  • Westlake/Thousand Oaks
  • Unity OB/GYN at Brockport
  • Clifton Springs Hospital & Clinic
  • Finger Lakes Geneva
  • TWC Newark
  • TWC Clinton
  • TWC at Alexander Park
  • Community OB (COB)
  • URMC Midwifery at Culver
  • UMG OBGYN St Marys
  • Parkway OBGYN
  • UMG OBGYN Clinton Crossings
  • Gender Wellness Obstetrics & Gynecology (GOG)
  • Highland Women's Health (HWH) (POB)
  • University OB/GYN (UOG)
  • URMC Midwifery at Lattimore
  • TWC at RGH (Portland)
  • Strong Perinatal Associates (SPA)
  • Park Ridge OBGYN
  • Unity OB/GYN at Ridgeway
  • Bay Creek Midwifery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VAX-MOM COVID-19 Intervention

Standard of Care

Arm Description

Outcomes

Primary Outcome Measures

Rate of COVID-19 vaccination
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.

Secondary Outcome Measures

Full Information

First Posted
September 29, 2022
Last Updated
August 31, 2023
Sponsor
University of Rochester
Collaborators
Centers for Disease Control and Prevention, University of California, Los Angeles
search

1. Study Identification

Unique Protocol Identification Number
NCT05570630
Brief Title
VAX-MOM COVID-19: Increasing Maternal COVID-19 Vaccination
Official Title
VAX-MOM COVID-19: Increasing Maternal COVID-19 Vaccination
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 21, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
Centers for Disease Control and Prevention, University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunization; Infection, Pregnancy Related, COVID-19
Keywords
COVID-19, Vaccination, Prenatal Care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VAX-MOM COVID-19 Intervention
Arm Type
Experimental
Arm Title
Standard of Care
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
VAX-MOM COVID-19 Intervention
Intervention Description
The multi-component VAX-MOM COVID-19 intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Standard vaccine education and processes provided to patients by obstetric practices.
Primary Outcome Measure Information:
Title
Rate of COVID-19 vaccination
Description
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
6 month baseline compared to 6 month intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Ronald Reagan
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Pasadena
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Porter Ranch
City
Porter Ranch
State/Province
California
ZIP/Postal Code
91326
Country
United States
Facility Name
Santa Monica
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
South Bay: Torrance
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
Facility Name
Westlake/Thousand Oaks
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Unity OB/GYN at Brockport
City
Brockport
State/Province
New York
ZIP/Postal Code
14420
Country
United States
Facility Name
Clifton Springs Hospital & Clinic
City
Clifton Springs
State/Province
New York
ZIP/Postal Code
14432
Country
United States
Facility Name
Finger Lakes Geneva
City
Geneva
State/Province
New York
ZIP/Postal Code
14456
Country
United States
Facility Name
TWC Newark
City
Newark
State/Province
New York
ZIP/Postal Code
14513
Country
United States
Facility Name
TWC Clinton
City
Rochester
State/Province
New York
ZIP/Postal Code
14605
Country
United States
Facility Name
TWC at Alexander Park
City
Rochester
State/Province
New York
ZIP/Postal Code
14607
Country
United States
Facility Name
Community OB (COB)
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
URMC Midwifery at Culver
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
UMG OBGYN St Marys
City
Rochester
State/Province
New York
ZIP/Postal Code
14611
Country
United States
Facility Name
Parkway OBGYN
City
Rochester
State/Province
New York
ZIP/Postal Code
14612
Country
United States
Facility Name
UMG OBGYN Clinton Crossings
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Gender Wellness Obstetrics & Gynecology (GOG)
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Highland Women's Health (HWH) (POB)
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
University OB/GYN (UOG)
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
URMC Midwifery at Lattimore
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
TWC at RGH (Portland)
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Facility Name
Strong Perinatal Associates (SPA)
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Park Ridge OBGYN
City
Rochester
State/Province
New York
ZIP/Postal Code
14626
Country
United States
Facility Name
Unity OB/GYN at Ridgeway
City
Rochester
State/Province
New York
ZIP/Postal Code
14626
Country
United States
Facility Name
Bay Creek Midwifery
City
Webster
State/Province
New York
ZIP/Postal Code
14580
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared with investigators upon request as part of a collaboration.

Learn more about this trial

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

We'll reach out to this number within 24 hrs