- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02428738
Text Message Reminders for Influenza Vaccine in Pregnancy
February 20, 2019 updated by: Unity Health Toronto
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
317
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5B 1W8
- St. Michael's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
All Women cared for in the Women's Health Care Centre prenatal clinic during influenza season
Description
Inclusion Criteria:
- Pregnant Woman
- Ages 18 and over
- Working cellular telephone with the ability to receive text messages
- Ability to speak or understand English
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of Influenza Vaccination of those who do receive text message reminders compared to those who do not.
Time Frame: Up to 5 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient characteristics affecting liklihood of receiving vaccine
Time Frame: Up to 5 months
|
Patient characteristics (e.g.
race/ethnicity, education level, family income, number of prior pregnancies, history of receiving the vaccine in the past) affecting the likelihood of receiving the vaccine among those who receive reminders.
|
Up to 5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (ACTUAL)
January 1, 2014
Study Completion (ACTUAL)
March 1, 2014
Study Registration Dates
First Submitted
April 16, 2015
First Submitted That Met QC Criteria
April 23, 2015
First Posted (ESTIMATE)
April 29, 2015
Study Record Updates
Last Update Posted (ACTUAL)
February 22, 2019
Last Update Submitted That Met QC Criteria
February 20, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-265
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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