Influenza and Text Messaging in Pregnancy

University of Pittsburgh

Status: Completed

Conditions: Pregnancy

Treatments: Other: influenza and general health information; Other: general health information

Study type: Interventional

Funder types: Other

Identifiers

NCT01248520

PRO09100504

Details and patient eligibility

About

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

Full 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.

Enrollment: 216 patients

Sex: Female

Ages: 14 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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216 participants in 2 patient groups, including a placebo group

General health information

Placebo Comparator group

Description:

Pregnant women receiving text messages containing general health messages without including information regarding the importance of the influenza vaccination

Treatment:

Other: general health information

Influenza and general health information

Active Comparator group

Description:

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

Treatment:

Other: influenza and general health information