Influenza and Text Messaging in Pregnancy

Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01248520
• Other study ID #: PRO09100504
• Status: Completed
• Phase: N/A
• Start date: September 2010
• Est. completion date: April 2014

Study information

• Verified date: December 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: April 2014
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Influenza, Human
• Pregnancy

Intervention

Other:
• influenza and general health 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.
• general health information
Subjects assigned to the influenza information group will receive health text messages from the time they enroll until they deliver.

Locations

Country	Name	City	State
United States	Magee-Womens Hospital of UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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