Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000553774
Ethics application status
Not yet submitted
Date submitted
27/02/2013
Date registered
16/05/2013
Date last updated
23/07/2019
Date data sharing statement initially provided
23/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Text message reminder to increase influenza vaccination during pregnancy in women booked for pregnancy and birth care at Mercy Hospital for Women: a Pilot study
Scientific title
Text message reminder to increase influenza vaccination during pregnancy in women booked for pregnancy and birth care at Mercy Hospital for Women
Secondary ID [1] 282034 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vaccination 288487 0
Pregnancy 288488 0
Influenza 288489 0
Condition category
Condition code
Reproductive Health and Childbirth 288832 288832 0 0
Fetal medicine and complications of pregnancy
Reproductive Health and Childbirth 288833 288833 0 0
Antenatal care
Public Health 288953 288953 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A text message: "MSG from Mercy Hosp: Flu vacc is good for mums and babies. Talk to your midwife or dr. soon". The message will be sent once per pregnancy, anticipating about 10 recipients per week over 10 weeks from availability of influenza vaccination (usually after March each year). This will be in addition to standard antenatal care in 2013 which is the same as standard antenatal care in 2012.
Intervention code [1] 286624 0
Prevention
Comparator / control treatment
Standard antenatal care in 2010,2011, 2012 and 2013. This included an information brochure about vaccinations during and after pregnancy included in documents given to women at antenatal booking, a reminder stamp in the hospital antenatal clinic notes once seasonal influenza vaccine is available and a seasonal staff education campaign including a grand round lecture, reminders at weekly unit audit meetings and midwifery staff handover meetings. Outcomes, defined as influenza vaccination coverage and detailed later in this registration document, are available from previous audits at Mercy Hospital for Women in 2010, 2011 and 2012
Control group
Historical

Outcomes
Primary outcome [1] 288965 0
The rate of influenza vaccination uptake during pregnancy as judged by surveillance data from an interview based annual audit of mothers giving birth over 14 consecutive days at Mercy Hospital for Women, a sample expected to comprise about 220 women.
Timepoint [1] 288965 0
Assessed once during first few days postpartum which is approximately 2 to 20 weeks after intervention. The timepoint is July 2013 and will be compared compared with surveillance data collected using the same audit techniques during July 2012, July 2011 and July 2010.
Secondary outcome [1] 301462 0
The rate of women who recall receiving a text message reminder about influenza from the Mercy Hospital or other sources as judged by surveillance data from an interview based annual audit of mothers giving birth over 14 consecutive days at Mercy Hospital for Women, a sample expected to comprise about 220 women
Timepoint [1] 301462 0
Assessed once during first few days postpartum which is approximately 2 to 20 weeks after intervention. The timepoint is July 2013 and will be compared compared with surveillance data collected using the same audit techniques during July 2012. Audits before this time did not enquire about text message as a source of information about influenza vaccine.
Secondary outcome [2] 301463 0
The rate of women reporting "no health professional mentioned influenza vaccine during my pregnancy" as judged by surveillance data from an interview based annual audit of mothers giving birth over 14 consecutive days at Mercy Hospital for Women, a sample expected to comprise about 220 women
Timepoint [2] 301463 0
Assessed once during first few days postpartum which is approximately 2 to 20 weeks after intervention. The timepoint is July 2013 and will be compared compared with surveillance data collected using the same audit techniques during July 2012, July 2011 and July 2010.
Secondary outcome [3] 301464 0
The rate of women answering yes to "I would be interested in a text message reminder about influenza vaccination" as judged by surveillance data from an interview based annual audit of mothers giving birth over 14 consecutive days at Mercy Hospital for Women, a sample expected to comprise about 220 women
Timepoint [3] 301464 0
Assessed once during first few days postpartum which is approximately 2 to 20 weeks after intervention. The timepoint is July 2013 and will be compared compared with surveillance data collected using the same audit techniques during July 2012. Audits before this time did not enquire about text message as a source of information about influenza vaccine.
Secondary outcome [4] 301465 0
Qualitative feedback on preferred sources of information about, promoters of and obstacles to influenza vaccination during pregnancy as judged by surveillance data from an interview based annual audit of mothers giving birth over 14 consecutive days at Mercy Hospital for Women, a sample expected to comprise about 220 women
Timepoint [4] 301465 0
Assessed once during first few days postpartum which is approximately 2 to 20 weeks after intervention. The timepoint is July 2013 and will be compared compared with surveillance data collected using the same audit techniques during July 2012. Audits before this time did not enquire about women's preferred sources of information.

Eligibility
Key inclusion criteria
Women who are 1. booked for pregnancy and birth care at Mercy Hospital for Women, 2. who have not opted out of the Hospital contacting them as per their Privacy Consent form, 3. who have listed a mobile telephone number with the hospital and 4. who have had a reassuring report on fetal growth and wellbeing at their midtrimester routine fetal anomaly ultrasound scan
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Privacy Consent form indicates the person declines being contacted by the Hospital. Inability to confirm a normal routine midtrimester fetal anomaly ultrasound scan.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An attempt will be made to contact all eligible women who have had midtrimester ultrasound scan reports from early February 2013. The size of the intervention group is likely to be limited to about 100, mainly because of 1. access to midtrimester ultrasound reports will be most simple using the Hospital Viewpoint ultrasound reporting package, only used by about 10% of patients 2. resource limitations of access to the hospital text message service 3. staff time limitations
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence of participants for intervention will be determined by the schedule of ultrasound appointments at Mercy Hospital for Women
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
The extent of the intervention is currently limited by 2 factors: 1. the intervention will only be carried out for women with readily accessible midtrimester scan reports performed at the hospital and the 2. available researcher hours. The outcome will currently be assessed using an annual audit which is part of standard hospital practice. More rigorously extending the intervention to an ideally unbiased sample and more vigorously assessing outcomes for women exposed to the intervention may be possible in future studies. Future study designs will be informed by feasibility data collected in the current study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Previous hospital audits have documented influenza vaccination rates among pregnant women of 30% in 2010, 40% in 2011 and 36% in 2012.
The planned 2013 audit over a 14 day period will likely involve 220 new mothers. This is a sufficiently large sample size to show an increase in from 88 to 119 vaccinated women or 40% to 54%, p = 0.05 (2 sided), 80% power

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/04/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 696 0
Mercy Hospital for Women - Heidelberg
Recruitment postcode(s) [1] 6435 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 286813 0
University
Name [1] 286813 0
University of Melbourne, Department of Obstetrics and Gynaecology
Country [1] 286813 0
Australia
Primary sponsor type
University
Name
University of Melbourne, Department of Obstetrics and Gynaecology
Address
Perinatal Centre, Mercy Hospital for Women
Level 3, 163 Studley Road
Heidelberg 3084
VIC
Country
Australia
Secondary sponsor category [1] 285602 0
None
Name [1] 285602 0
Address [1] 285602 0
Country [1] 285602 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288880 0
Mercy Health Human Research and Ethics Committee
Ethics committee address [1] 288880 0
Level 6, Mercy Hospital for Women
163 Studley Road
Heidelberg 3084
VIC
Ethics committee country [1] 288880 0
Australia
Date submitted for ethics approval [1] 288880 0
04/03/2013
Approval date [1] 288880 0
Ethics approval number [1] 288880 0

Summary
Brief summary
Influenza vaccination is recommended during pregnancy to protect 1. pregnant women 2. unborn babies and 3. infants within the first 6 months of life. Because of this “3 for 1” protection, the World Health Organisation prioritises pregnant women as highest among those who should receive influenza vaccination. Influenza vaccine prevents infection complications including critical maternal illness and death, stillbirth, fetal growth restriction, premature birth and serious infection in the first 6 months of life. Babies under the age of 6 months are too young to receive influenza vaccination directly. But babies whose mothers were vaccinated are protected in three ways: 1. antibodies which have crossed the placenta during fetal life stay in babies’ blood for up to 6 months 2. babies get more antibodies in breast milk 3. the baby is “cocooned”, meaning that he or she is unlikely to become infected with influenza from their nearest adult contact, their mother.
Despite well studied safety of influenza vaccination during pregnancy, midwives, obstetricians and pregnant women are not well informed about benefits and safety. Previous audits at Mercy Hospital for Women showed that patient information brochures, staff education and reminder stamps in antenatal clinic progress notes increased influenza vaccination from 30% to 40% between 2010 and 2011. By winter 2012, we could not show any further increase, despite hoping that more than 75% of new mothers would have had influenza vaccination before their babies were born. A significant group of pregnant women do not recall influenza vaccination being discussed by obstetric or midwifery staff during pregnancy.
This project aims to increase awareness and discussion about influenza vaccination using a text message reminder to women booked to have their baby at Mercy Hospital for Women during the influenza season 2013 (approximately March to October). The text message will read “ Msg from Mercy Hosp: Flu vacc in pregnancy is good for mums & babies. Ask your midwife or dr. about it soon”. Text messages are a familiar sort of appointment reminder used by hairdressers, dentists etc. Audit of new mothers in 2012 found that 80% of women were interested in text, email or web-based reminders or information in additional to written information and talking with their doctor or midwife. Published research on text messages and vaccination in the United States also indicate around 80% uptake and even higher levels of acceptability for pregnant women and families with children.
The Mercy Hospital for Women already uses a text message service for the nurse bank. Pregnant women will only be contacted if their privacy consent permits the hospital to contact them. Pregnant women will only be contacted if their mid trimester ultrasound indicates reassuring fetal development. In this way, women who have already suffered a miscarriage will not receive a text message. Women with significant fetal anomalies will not be contacted as part of research. Such women are usually referred to Perinatal Medicine where influenza vaccination is also offered as part of routine care.
We plan to assess influenza uptake by auditing new mothers on the postnatal wards in July and/or August 2013. Almost identical audits occurred previously in 2010, 2011 and 2012 using a 5minute interview technique which has previously been well received and been able to gain the views of 95% or more new mothers about why or why not they chose vaccination. No identifying data is collected but summary data is important for quality improvement.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38178 0
Dr Elizabeth McCarthy
Address 38178 0
Perinatal Centre, Level 3
Mercy Hospital for Women
163 Studley Road
Heidelberg VIC 3084
Country 38178 0
Australia
Phone 38178 0
+61384584248
Fax 38178 0
+61384584054
Email 38178 0
[email protected]
Contact person for public queries
Name 38179 0
Elizabeth McCarthy
Address 38179 0
Perinatal Centre, Level 3
Mercy Hospital for Women
163 Studley Road
Heidelberg VIC 3084
Country 38179 0
Australia
Phone 38179 0
+61384584248
Fax 38179 0
Email 38179 0
[email protected]
Contact person for scientific queries
Name 38180 0
Elizabeth McCarthy
Address 38180 0
Perinatal Centre, Level 3
Mercy Hospital for Women
163 Studley Road
Heidelberg VIC 3084
Country 38180 0
Australia
Phone 38180 0
+61384584248
Fax 38180 0
Email 38180 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No data to share


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.