Clinical trial NCT01761799: Protecting Pregnant Women From Infectious Diseases
Official title: Protecting Pregnant Women From Infectious Diseases: a Cluster Randomized Evaluation of the Comprehensive "P3" Intervention Package Within Obstetric Practices in Georgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Pertussis
Keywords: Influenza
Pertussis
Vaccination
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2013-01-07
Enrollment: 330
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Receipt of influenza vaccine during pregnancy
timeFrame: 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:
measure: Receipt of Tdap vaccine during pregnancy
timeFrame: 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:
measure: Changes in maternal knowledge, attitudes and beliefs regarding maternal and infant vaccination
timeFrame: 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.
Locations:
city: Athens
country: United States
facility: Athens OBGYN
state: Georgia
city: Athens
country: United States
facility: Women's Healthcare Associates
state: Georgia
city: Atlanta
country: United States
facility: Emory Clinic A, Clifton Road Clinic
state: Georgia
city: Bogart
country: United States
facility: Women's Center of Athens
state: Georgia
city: Cumming
country: United States
facility: North Pointe OB/GYN
state: Georgia
city: Fayetteville
country: United States
facility: Southern Crescent Women's Health Care
state: Georgia
city: Macon
country: United States
facility: W.T. Anderson Health Center - MCCG
state: Georgia
city: Riverdale
country: United States
facility: My OB/GYN
state: Georgia
city: Riverdale
country: United States
facility: New Millennium OB/GYN
state: Georgia
city: Statesboro
country: United States
facility: Statesboro OB/GYN Specialists
state: Georgia
city: Thomasville
country: United States
facility: Shaw Center for Women's Health
state: Georgia
Study officials:
affiliation: Emory Unversity
name: Saad B Omer, MBBS,MPH,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Chamberlain 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.