NCT01248520

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 25, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

December 13, 2018

Status Verified

December 1, 2018

Enrollment Period

1.7 years

First QC Date

November 23, 2010

Last Update Submit

December 12, 2018

Conditions

Pregnancy

Keywords

PregnancyInfluenza Vaccination

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • To assess the ability of direct education via text messaging to enhance knowledge about influenza infection and vaccination in pregnancy.

    at participant post-partum visit

Study Arms (2)

General health information

PLACEBO COMPARATOR

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

Other: general health information

Influenza and general health information

ACTIVE COMPARATOR

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

Interventions

influenza and general health informationOTHER

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.

Influenza and general health information
general health informationOTHER

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

General health information

Eligibility Criteria

Age14 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • 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.

    PMID: 23635672DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Michelle Moniz, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 23, 2010

First Posted

November 25, 2010

Study Start

September 1, 2010

Primary Completion

May 1, 2012

Study Completion

April 1, 2014

Last Updated

December 13, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)