Protecting Pregnant Women From Infectious Diseases
2 other identifiers
interventional
330
1 country
11
Brief Summary
The primary research aim of this project is to test the effectiveness of a comprehensive, evidence-based vaccine promotion package implemented in the obstetric setting on increasing the likelihood that a pregnant woman in Georgia will receive an influenza and/or pertussis vaccine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2012
Typical duration for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 18, 2012
CompletedFirst Posted
Study publicly available on registry
January 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedNovember 2, 2015
October 1, 2015
1.2 years
December 18, 2012
October 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Receipt of influenza vaccine during pregnancy
Our primary outcome is receipt of a 2012 - 2013 seasonal influenza vaccine during a participant's current pregnancy, before she delivers her child(ren).
Participants will be followed for the remaining duration of their pregnancy, which will range from approximately 2 weeks to 7 months depending upon their gestation at enrollment.
Secondary Outcomes (1)
Receipt of Tdap vaccine during pregnancy
Participants will be followed for the remaining duration of their pregnancy, which will range from approximately 2 weeks to 7 months depending upon their gestation at enrollment.
Other Outcomes (1)
Changes in maternal knowledge, attitudes and beliefs regarding maternal and infant vaccination
Participants will be followed for the remaining duration of their pregnancy, which will range from approximately 2 weeks to 7 months depending upon their gestation at enrollment.
Study Arms (2)
P3 Vaccine Promotion Package
EXPERIMENTALThe 5 obstetric practices randomized to the intervention arm will receive and implement all components of the evidence-based P3 vaccine promotion package at the beginning of the study.
No P3 vaccine promotion package intervention
NO INTERVENTIONThe 5 obstetric practices randomized to the control arm will not receive the comprehensive vaccine promotion package at the beginning of the study and will instead be instructed to continue their standard of care regarding influenza and Tdap vaccination of pregnant patients.
Interventions
"P3" stands for Practice, Provider, and Patient level vaccine promotion package. The 5 obstetric practices randomized to the intervention arm will receive this comprehensive influenza and Tdap vaccine promotion package at the beginning of the study. Physicians and staff will be familiarized with each component, and practices will be instructed to implement each component to the best of their ability. The components include: posters, educational brochures, lapel buttons, provider-to-patient talking points, lists of nearby locations offering flu and/or Tdap vaccines (if not offered by the practice), identification of a "vaccine champion" within the practice, provider and staff training on vaccination during pregnancy, and use of an interactive, tablet-based educational tutorial for patients.
Eligibility Criteria
You may qualify if:
- Between the ages of 18 - 50
- Currently pregnant
- Unvaccinated with 2012 - 2013 seasonal influenza vaccine
- Unvaccinated with Tdap vaccine during current pregnancy
You may not qualify if:
- Under 18 years of age or over 50
- Not currently pregnant
- Previous receipt of 2012 - 2013 seasonal influenza vaccine
- Previous receipt of Tdap vaccine during current pregnancy
- Does not speak English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- Centers for Disease Control and Preventioncollaborator
Study Sites (11)
Athens OBGYN
Athens, Georgia, 30606, United States
Women's Healthcare Associates
Athens, Georgia, 30606, United States
Emory Clinic A, Clifton Road Clinic
Atlanta, Georgia, 30322, United States
Women's Center of Athens
Bogart, Georgia, 30622, United States
North Pointe OB/GYN
Cumming, Georgia, 30041, United States
Southern Crescent Women's Health Care
Fayetteville, Georgia, 30214, United States
W.T. Anderson Health Center - MCCG
Macon, Georgia, 31201, United States
My OB/GYN
Riverdale, Georgia, 30274, United States
New Millennium OB/GYN
Riverdale, Georgia, 30274, United States
Statesboro OB/GYN Specialists
Statesboro, Georgia, 30458, United States
Shaw Center for Women's Health
Thomasville, Georgia, 31792, United States
Related Publications (2)
Chamberlain AT, Seib K, Ault KA, Rosenberg ES, Frew PM, Cortes M, Whitney EA, Berkelman RL, Orenstein WA, Omer SB. Improving influenza and Tdap vaccination during pregnancy: A cluster-randomized trial of a multi-component antenatal vaccine promotion package in late influenza season. Vaccine. 2015 Jul 9;33(30):3571-9. doi: 10.1016/j.vaccine.2015.05.048. Epub 2015 Jun 1.
PMID: 26044495RESULTChamberlain AT, Seib K, Ault KA, Rosenberg ES, Frew PM, Cortes M, Whitney EA, Berkelman RL, Orenstein WA, Omer SB. Impact of a multi-component antenatal vaccine promotion package on improving knowledge, attitudes and beliefs about influenza and Tdap vaccination during pregnancy. Hum Vaccin Immunother. 2016 Aug 2;12(8):2017-2024. doi: 10.1080/21645515.2015.1127489. Epub 2016 Apr 15.
PMID: 27082036DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Saad B Omer, MBBS,MPH,PhD
Emory Unversity
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
- Assistant Professor Global Health, Epidemiology, and Pediatrics, Emory University, Schools of Public Health & Medicine & Emory Vaccine Center
Study Record Dates
First Submitted
December 18, 2012
First Posted
January 7, 2013
Study Start
December 1, 2012
Primary Completion
February 1, 2014
Study Completion
August 1, 2015
Last Updated
November 2, 2015
Record last verified: 2015-10