NCT02428738

Brief Summary

Influenza virus accounts for numerous cases (epidemics) of respiratory illnesses each year worldwide and affects people of all ages. These epidemics typically occur in the winter months, and can result in substantial morbidity and mortality in persons at risk. Pregnant women may be more susceptible to morbidity and mortality associated with influenza infection. This increased risk may result from several factors including increased heart rate, stroke volume, and oxygen consumption, decreased lung capacity, and changes in immunologic function. Immunization of women during pregnancy can help to prevent infection in the woman herself and may also offer protection to the infant in two ways: by the passage of antibodies from mother to the fetus during pregnancy, and by preventing infection in the mother and therefore decreasing the infant's exposure risk after birth. In Canada, the National Advisory Committee on Immunization (NACI) recommends the vaccine for pregnant women who are expected to deliver during influenza season because they will become household contacts of their newborn. Ideal timing of vaccination occurs in October or November since influenza outbreaks typically occur throughout the winter months. Despite the Canadian and American guidelines for influenza vaccination during pregnancy, it is unclear how many women are offered and/or actually receive the vaccine while pregnant. There is, however, evidence that women will accept the vaccine if offered. Specifically, in the Women's Health Care Centre at St. Michael's Hospital, it was found that 42% of women not only accepted but also received the influenza vaccination when offered. Innovative techniques will be required to continue to increase vaccination rates among vulnerable populations, including pregnant women. The purpose of the present study is to determine if the use of electronic reminders (text messages) increases the likelihood of receiving the influenza vaccine among pregnant women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
317

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2013

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 29, 2015

Completed
Last Updated

February 22, 2019

Status Verified

February 1, 2019

Enrollment Period

2 months

First QC Date

April 16, 2015

Last Update Submit

February 20, 2019

Conditions

Keywords

Influenza VaccineText Message

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Influenza Vaccination of those who do receive text message reminders compared to those who do not.

    To determine the percentage of women who receive the influenza vaccine during pregnancy and also received text message reminders, relative to women who do not receive text messages.

    Up to 5 months

Secondary Outcomes (1)

  • Patient characteristics affecting liklihood of receiving vaccine

    Up to 5 months

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All Women cared for in the Women's Health Care Centre prenatal clinic during influenza season

You may qualify if:

  • Pregnant Woman
  • Ages 18 and over
  • Working cellular telephone with the ability to receive text messages
  • Ability to speak or understand English

You may not qualify if:

  • Age less than 18
  • Inability to speak or understand English
  • Not possessing a working cellular telephone with text messaging capability
  • Presence of any contraindications to vaccination (such as egg allergy or prior adverse reaction to the vaccine)
  • Women who have already received the vaccine during this influenza season

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (1)

  • Yudin MH, Mistry N, De Souza LR, Besel K, Patel V, Blanco Mejia S, Bernick R, Ryan V, Urquia M, Beigi RH, Moniz MH, Sgro M. Text messages for influenza vaccination among pregnant women: A randomized controlled trial. Vaccine. 2017 Feb 1;35(5):842-848. doi: 10.1016/j.vaccine.2016.12.002. Epub 2017 Jan 3.

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Mark Yudin, MD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2015

First Posted

April 29, 2015

Study Start

November 1, 2013

Primary Completion

January 1, 2014

Study Completion

March 1, 2014

Last Updated

February 22, 2019

Record last verified: 2019-02

Locations