Clinical Trial: Protecting Pregnant Women From Infectious Diseases

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Protecting Pregnant Women From Infectious Diseases: a Cluster Randomized Evaluation of the Comprehensive "P3" Intervention Package Within Obstetric Practices in Georgia

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 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 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.
Sponsor: Emory University

Current Primary Outcome: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome: 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).


Original Secondary Outcome: Same as current

Information By: Emory University

Dates:
Date Received: December 18, 2012
Date Started: December 2012
Date Completion:
Last Updated: October 30, 2015
Last Verified: October 2015