Influenza and Text Messaging in Pregnancy

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

Detailed Description
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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.

Official Title
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Text Messaging For Preventative Health During Pregnancy; Improving Influenza Vaccination Rates In Pregnancy: A Randomized Controlled Trial of Text Messaging to Increase Vaccine Uptake

Conditions
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Pregnancy

Intervention / Treatment
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* Other: influenza and general health information
* Other: general health information


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: General health information<br>Pregnant women receiving text messages containing general health messages without including information regarding the importance of the influenza vaccination | Other: general health information<br>* Subjects assigned to the influenza information group will receive health text messages from the time they enroll until they deliver.<br>|
| Active Comparator: Influenza and general health information<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the ability of direct communication and education to patients using modern technology (cellular text messaging) to enhance vaccine uptake. | 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. | at participant post-partum visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the ability of direct education via text messaging to enhance knowledge about influenza infection and vaccination in pregnancy. | 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. | at participant post-partum visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Influenza Vaccination