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Protecting Pregnant Women From Infectious Diseases

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ClinicalTrials.gov Identifier: NCT01761799
Recruitment Status : Completed
First Posted : January 7, 2013
Last Update Posted : November 1, 2015
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Saad B. Omer, PhD, Emory University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Influenza Pertussis Behavioral: P3 Vaccine Promotion Package. Not Applicable

Detailed Description:
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 vaccine and/or Tdap vaccine before delivery. A secondary research aim assesses whether the comprehensive package improves maternal knowledge, attitudes, and beliefs regarding maternal and infant vaccination. The intervention package will include evidence-based components aimed at the practice-level, provider-level, and patient level and will be tested through a cluster-randomized trial design. The primary outcome measure is influenza vaccine receipt during pregnancy. The secondary outcomes include 1) receipt of pertussis (Tdap) vaccination during pregnancy, and 2) changes in maternal knowledge, attitudes and beliefs regarding maternal and infant vaccination. The primary hypothesis is that implementation of a comprehensive vaccine promotion package in the obstetric setting will increase the likelihood that a pregnant woman receives an influenza and/or pertussis vaccination.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Protecting Pregnant Women From Infectious Diseases: a Cluster Randomized Evaluation of the Comprehensive "P3" Intervention Package Within Obstetric Practices in Georgia
Study Start Date : December 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : August 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: P3 Vaccine Promotion Package
The 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.
 Behavioral: P3 Vaccine Promotion Package.
"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.
No Intervention: No P3 vaccine promotion package intervention
The 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.


Outcome Measures
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Primary Outcome Measures :
  1. Receipt of influenza vaccine during pregnancy [ Time Frame: 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. ]
    Our primary outcome is receipt of a 2012 - 2013 seasonal influenza vaccine during a participant's current pregnancy, before she delivers her child(ren).


Secondary Outcome Measures :
  1. Receipt of Tdap vaccine during pregnancy [ Time Frame: 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. ]
    A secondary outcome is receipt of a Tdap vaccine during a participant's current pregnancy, before she delivers her child(ren).


Other Outcome Measures:
  1. Changes in maternal knowledge, attitudes and beliefs regarding maternal and infant vaccination [ Time Frame: 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. ]
    This secondary outcome will be assessed through two surveys: one survey administered at baseline upon enrollment, and another survey administered 2 - 3 months post-partum.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Between the ages of 18 - 50
  • Currently pregnant
  • Unvaccinated with 2012 - 2013 seasonal influenza vaccine
  • Unvaccinated with Tdap vaccine during current pregnancy

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761799


Locations
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United States, Georgia
Athens OBGYN
Athens, Georgia, United States, 30606
Women's Healthcare Associates
Athens, Georgia, United States, 30606
Emory Clinic A, Clifton Road Clinic
Atlanta, Georgia, United States, 30322
Women's Center of Athens
Bogart, Georgia, United States, 30622
North Pointe OB/GYN
Cumming, Georgia, United States, 30041
Southern Crescent Women's Health Care
Fayetteville, Georgia, United States, 30214
W.T. Anderson Health Center - MCCG
Macon, Georgia, United States, 31201
My OB/GYN
Riverdale, Georgia, United States, 30274
New Millennium OB/GYN
Riverdale, Georgia, United States, 30274
Statesboro OB/GYN Specialists
Statesboro, Georgia, United States, 30458
Shaw Center for Women's Health
Thomasville, Georgia, United States, 31792
Sponsors and Collaborators
Emory University
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Saad B Omer, MBBS,MPH,PhD Emory Unversity
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Saad B. Omer, PhD, Assistant Professor Global Health, Epidemiology, and Pediatrics, Emory University, Schools of Public Health & Medicine & Emory Vaccine Center, Emory University
ClinicalTrials.gov Identifier: NCT01761799    
Other Study ID Numbers: IRB00060292
5P01TP000300-05 ( U.S. NIH Grant/Contract )
First Posted: January 7, 2013    Key Record Dates
Last Update Posted: November 1, 2015
Last Verified: October 2015
Keywords provided by Saad B. Omer, PhD, Emory University:
Influenza
Pertussis
Vaccination
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Whooping Cough
Respiratory Tract Infections
 Respiratory Tract Diseases
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections