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Completed

NCT Number: NCT01248520

Influenza and Text Messaging in Pregnancy

A randomized, controlled clinical trial to assess whether text messaging to an outpatient obstetric population can improve maternal influenza vaccine uptake.

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Key information

Age range

14 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Unwillingness or inability to receive text messages
  • Receipt of the current season's influenza vaccine or plan to receive the influenza vaccine on the day of the enrollment visit
  • Reported history of adverse reaction precluding receipt of the vaccine
  • Unwillingness or inability to provide informed consent and comply with study criteria.

Treatment and study plan

influenza and general health information

Other

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.

general health information

Other

Subjects assigned to the influenza information group will receive health text messages from the time they enroll until they deliver.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2014
First posted
Nov 25, 2010
Registry last updated
Dec 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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