ClinicalTrials.gov
ClinicalTrials.gov Menu

Influenza and Text Messaging in Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01248520
Recruitment Status : Completed
First Posted : November 25, 2010
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
Richard Beigi, University of Pittsburgh

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
A randomized, controlled clinical trial to assess whether text messaging to an outpatient obstetric population can improve maternal influenza vaccine uptake.

Condition or disease Intervention/treatment Phase
Pregnancy Other: influenza and general health information Other: general health information Not Applicable

Detailed Description:
History and the 2009 H1N1 influenza pandemic suggest that both seasonal and pandemic influenza infections impart disproportionate morbidity and mortality among gravidas. The influenza vaccine represents a viable, preventive health intervention to mitigate disease burden for gravidas and their neonates. Despite the safety and efficacy of influenza vaccines, suboptimal maternal vaccination rates (13-24%) persist nationwide. Barriers to influenza vaccination during pregnancy include patient concerns about vaccine safety and unappreciated risk of influenza infection. Cellular phone text messaging has emerged as an innovative technology with advantages of ubiquity, rapid, confidential information transmission, and low cost. Text messaging may represent an effective way to educate pregnant women about their particular vulnerability to influenza infection and enhance influenza vaccine uptake. We propose a randomized, controlled clinical trial to assess whether text messaging to an outpatient obstetric population can improve maternal influenza vaccine uptake.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Text Messaging For Preventative Health During Pregnancy; Improving Influenza Vaccination Rates In Pregnancy: A Randomized Controlled Trial of Text Messaging to Increase Vaccine Uptake
Study Start Date : September 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Placebo Comparator: General health information
Pregnant women receiving text messages containing general health messages without including information regarding the importance of the influenza vaccination
 Other: general health information
Subjects assigned to the influenza information group will receive health text messages from the time they enroll until they deliver.
Active Comparator: Influenza and general health information
Pregnant women receiving text messages with influenza facts and the importance of the influenza vaccination, as well as general health messages Intervention: Text messages with influenza facts
 Other: influenza and general health information
Subjects assigned to the influenza information group will receive health text messages from the time they enroll until they deliver. These messages will contain general health information as well as information regarding influenza and the importance of vaccination during pregnancy.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. To assess the ability of direct communication and education to patients using modern technology (cellular text messaging) to enhance vaccine uptake. [ Time Frame: at participant post-partum visit ]
    To assess the ability of direct communication and education to patients using modern technology (cellular text messaging) to enhance vaccine uptake. We hypothesize that text messaging will improve the timing (earlier in flu season) and rate of receipt of influenza vaccination in pregnancy.


Secondary Outcome Measures :
  1. To assess the ability of direct education via text messaging to enhance knowledge about influenza infection and vaccination in pregnancy. [ Time Frame: at participant post-partum visit ]
    To assess the ability of direct education via text messaging to enhance knowledge about influenza infection and vaccination in pregnancy. We hypothesize that women receiving text messages will be more likely than controls to have accurate knowledge about pregnant women's increased susceptibility to influenza and about the vaccine's safety and efficacy in pregnancy.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   14 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Pregnant women less than 28 weeks estimated gestation age
  2. Between 14-50 years of age
  3. Willing to provide informed consent and undergo necessary study procedures

Exclusion Criteria:

  1. Unwillingness or inability to receive text messages
  2. Receipt of the current season's influenza vaccine or plan to receive the influenza vaccine on the day of the enrollment visit
  3. Reported history of adverse reaction precluding receipt of the vaccine
  4. Unwillingness or inability to provide informed consent and comply with study criteria.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01248520


Locations
United States, Pennsylvania
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Michelle Moniz, MD University of Pittsburgh
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Responsible Party: Richard Beigi, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01248520     History of Changes
Other Study ID Numbers: PRO09100504
First Posted: November 25, 2010    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Richard Beigi, University of Pittsburgh:
Pregnancy
Influenza Vaccination

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
 Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs