Influenza and Text Messaging in Pregnancy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Pittsburgh.
Recruitment status was  Active, not recruiting
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
  Purpose

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.


Condition Intervention
Influenza Vaccination
Other: influenza vaccination/general health/pregnancy information
Other: general health/pregnancy information

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 250
Study Start Date: September 2010
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.
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
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.

  Eligibility

Ages Eligible for Study:   14 Years to 50 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michelle Moniz, Resident, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01248520     History of Changes
Other Study ID Numbers: PRO09100504
Study First Received: November 23, 2010
Last Updated: March 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Pregnancy
Influenza Vaccination

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014