Protecting Pregnant Women From Infectious Diseases

Not Applicable

Completed

• Conditions: Pertussis; Influenza
• Interventions: Behavioral: P3 Vaccine Promotion Package.

• Registration Number: NCT01761799
• Lead Sponsor: Emory University

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.

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 Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-18
• Study First Submitted QC: 2013-01-03
• Study First Posted: 2013-01-07
• Primary Completion: 2014-02
• Study Completion: 2015-08
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-30
• Last Update Posted: 2015-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 330

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P3 Vaccine Promotion Package	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.

Primary Outcome Measures

Name	Time	Method
Receipt of influenza 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.	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

Name	Time	Method
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.	A secondary outcome is receipt of a Tdap vaccine during a participant's current pregnancy, before she delivers her child(ren).

Trial Locations

Locations (11)

Athens OBGYN; 🇺🇸 Athens, Georgia, United States

Women's Healthcare Associates; 🇺🇸 Athens, Georgia, United States

Emory Clinic A, Clifton Road Clinic; 🇺🇸 Atlanta, Georgia, United States

Women's Center of Athens; 🇺🇸 Bogart, Georgia, United States

North Pointe OB/GYN; 🇺🇸 Cumming, Georgia, United States

Southern Crescent Women's Health Care; 🇺🇸 Fayetteville, Georgia, United States

W.T. Anderson Health Center - MCCG; 🇺🇸 Macon, Georgia, United States

My OB/GYN; 🇺🇸 Riverdale, Georgia, United States

New Millennium OB/GYN; 🇺🇸 Riverdale, Georgia, United States

Statesboro OB/GYN Specialists; 🇺🇸 Statesboro, Georgia, United States

Shaw Center for Women's Health; 🇺🇸 Thomasville, Georgia, United States