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Influenza and Text Messaging in Pregnancy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Michelle Moniz, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01248520
First received: November 23, 2010
Last updated: March 21, 2012
Last verified: March 2012
History of Changes

November 23, 2010
March 21, 2012
September 2010
May 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01248520 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Influenza and Text Messaging in Pregnancy
Text Messaging For Preventative Health During Pregnancy; Improving Influenza Vaccination Rates In Pregnancy: A Randomized Controlled Trial of Text Messaging to Increase Vaccine Uptake

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[1,2]. Despite the safety and efficacy of influenza vaccines, suboptimal maternal vaccination rates (13-24%) persist nationwide[3]. Barriers to influenza vaccination during pregnancy include patient concerns about vaccine safety and unappreciated risk of influenza infection[4]. 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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Influenza Vaccination
  • Other: influenza vaccination/general health/pregnancy 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.
  • Other: general health/pregnancy information
    Subjects assigned to the influenza information group will receive health text messages from the time they enroll until they deliver.
  • Placebo Comparator: text messages without influenza information
    Pregnant women will receive text messages containing health messages without including information regarding the importance of the influenza vaccination
    Intervention: Other: general health/pregnancy information
  • Active Comparator: text messages with influenza information
    Pregnant women will receive text messages containing health messages including information about the importance of the influenza vaccination
    Intervention: Other: influenza vaccination/general health/pregnancy information
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
250
Not Provided
May 2012   (final data collection date for primary outcome measure)

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.
Female
14 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01248520
PRO09100504
No
Michelle Moniz, University of Pittsburgh
University of Pittsburgh
Not Provided
Principal Investigator: Michelle Moniz, MD University of Pittsburgh
University of Pittsburgh
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP