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Influenza and Text Messaging in Pregnancy

NCT ID: NCT01248520

Last Updated: 2018-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2014-04-30

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.

Conditions

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Pregnancy

Keywords

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Pregnancy Influenza Vaccination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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General health information

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

Group Type PLACEBO_COMPARATOR

general health information

Intervention Type OTHER

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

Influenza and general health information

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

Group Type ACTIVE_COMPARATOR

influenza and general health information

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

general health information

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Richard Beigi

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michelle Moniz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23635672 (View on PubMed)

Other Identifiers

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PRO09100504

Identifier Type: -

Identifier Source: org_study_id