Clinical trial NCT01248520: Influenza and Text Messaging in Pregnancy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Pregnancy
Influenza Vaccination
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2010-11-25
Enrollment: 216
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: To assess the ability of direct communication and education to patients using modern technology (cellular text messaging) to enhance vaccine uptake.
timeFrame: at participant post-partum visit
Secondary outcomes:
measure: To assess the ability of direct education via text messaging to enhance knowledge about influenza infection and vaccination in pregnancy.
timeFrame: at participant post-partum visit
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital of UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Michelle Moniz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moniz MH, Hasley S, Meyn LA, Beigi RH. Improving influenza vaccination rates in pregnancy through text messaging: a randomized controlled trial. Obstet Gynecol. 2013 Apr;121(4):734-740. doi: 10.1097/AOG.0b013e31828642b1.