PregnancyNCT02428738
Text Message Reminders for Influenza Vaccine in Pregnancy
An observational study of Pregnancy, run by Unity Health Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- How many people
- 317 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2013to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All Women cared for in the Women's Health Care Centre prenatal clinic during influenza season
Who may be able to join
- Pregnant Woman
- Ages 18 and over
- Working cellular telephone with the ability to receive text messages
- Ability to speak or understand English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pregnancy
- Keywords
- Influenza Vaccine, Text Message
- Medical subject headings
- Influenza, Human
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 months
Secondary outcomes (1)
Patient characteristics affecting liklihood of receiving vaccine
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.
Measured: Up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startNov 2013
- Primary completionJan 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Yudin, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428738
- Sponsor's protocol ID
- 13-265
- Status last verified
- Feb 2019
- First submitted
- 16 Apr 2015
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28062124
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text Message Reminders for Influenza Vaccine in Pregnancy
- ClinicalTrials.gov ID
- NCT02428738
- Acronym / sponsor ID
- 13-265
- Conditions
- Pregnancy
- Keywords
- Influenza Vaccine, Text Message
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All Women cared for in the Women's Health Care Centre prenatal clinic during influenza season
Key inclusion criteria (4 listed)
- Pregnant Woman
- Ages 18 and over
- Working cellular telephone with the ability to receive text messages
- Ability to speak or understand English
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Patient characteristics affecting liklihood of receiving vaccine
Time frame: Up to 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
- Derived from this study: PubMed 28062124Yudin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Yudin, MD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Influenza Vaccination of those who do receive text message reminders compared to those who do not. (time frame: Up to 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02428738, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2019.