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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Maternal Pertussis Study: best practice for the communication of pertussis (whooping cough) booster vaccine recommendations to new mothers.
Scientific title
The influence of baseline attitudes, modifiable factors and health message framing on whooping cough booster vaccine uptake among new mothers on the postnatal ward in a public hospital.
Secondary ID [1] 282988 0
Universal Trial Number (UTN)
Nil Known
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pertussis 289815 0
Condition category
Condition code
Reproductive Health and Childbirth 290165 290165 0 0
Childbirth and postnatal care
Public Health 290166 290166 0 0
Health promotion/education
Infection 290182 290182 0 0
Other infectious diseases

Study type
Description of intervention(s) / exposure
Health-message framing: The tri-fold, coloured A4 pamphlet was written either in a gain or loss frame, indicating either what mothers gain from the cocooning strategy or what mothers would lose by not receiving the pertussis booster vaccine (for adults). The intervention was administered by the research nurse once the baseline questionnaire was completed. The interventions ( gain or loss pamphlet) were allocated to participants using sequential block allocation by week.
Intervention code [1] 287700 0
Comparator / control treatment
The control was the standard NSW Health pertussis facts sheet (A4, double sided). The printed factsheet was accessed from http://www.health.nsw.gov.au/factsheets/infectious/pertussis.html (Date: 14/SEPT/2009) and was the only available pertussis resource at the commencement of the study.
Control group

Primary outcome [1] 290193 0
Pertussis booster vaccine uptake by postpartum women, assessed by follow up questionnaire completed prior to discharge.
Timepoint [1] 290193 0
Immediate postpartum period (prior to discharge from hospital following childbirth).
Secondary outcome [1] 304084 0
Baseline attitude and other factors influencing vaccine uptake were assessed using a self-administered, paper-based questionnaire completed at the participant's bedside.

The questionnaire was comprised of 5 parts structure according to the Health Belief Model framework, with questions on: a) pertussis vaccination information sources b) pertussis susceptibility and severity c) vaccine benefits and barriers d) intentions to be vaccinated and e) demographic information.
Timepoint [1] 304084 0
At baseline (following completion of the baseline questionnaire, prior to allocation of the intervention or control).
Secondary outcome [2] 304085 0
Additional follow up ( by preferred method of phone or email) to assess household pertussis vaccine status and household exposure to pertussis and/or epidsode/s of pertussis.
Timepoint [2] 304085 0
from six months postpartum

Key inclusion criteria
Postpartum women not up to date with pertussis booster recommendations ( dTpa <10 years)
Minimum age
18 Years
Maximum age
No limit
Can healthy volunteers participate?
Key exclusion criteria
Requires an interpreter.
Unable to given written informed consent.

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All postpartum women present during recruitment days ( 3 week days) are approached sequentially (room by room on the postnatal ward) by the research nurse. Following consent, an paper-based, self-administered baseline questionnaire is completed. Next, the allocated intervention for that week is given to the participant by the research nurse.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
sequential block allocation by week
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Type of endpoint(s)
Statistical methods / analysis
A sample size of N=1080 is required to detect a difference between the gain-frame, loss-frame and control, with 80% confidence at the 0.05 level. This includes a 20% margin for non-response. Calculation based on vaccine coverage of 75%-80% post intervention.

Frequencies reported as percentages for all questions. Chi-square analysis to test for association of pertussis booster vaccine uptake and demographic, attitudinal, awareness and behavioural variables. Multiple logistic regression of significant variables in the univariate analysis is undertaken to determine predictors of vaccine uptake on the postnatal ward.

Recruitment status
Active, not recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 1426 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 7260 0
2065 - Royal North Shore Hospital

Funding & Sponsors
Funding source category [1] 287758 0
Commercial sector/Industry
Name [1] 287758 0
Sanofi Pasteur Pty Limited
Address [1] 287758 0
Talavera Corporate Centre, Building D
12-24 Talavera Road, Macquarie Park, NSW 2113
Country [1] 287758 0
Primary sponsor type
Associate Professor John Sinn
Department of Neonatology
Level 5 Douglas Building
Royal North Shore Hospital
Pacific Highway,
St Leonards, NSW, 2065
Secondary sponsor category [1] 286483 0
Name [1] 286483 0
Address [1] 286483 0
Country [1] 286483 0
Other collaborator category [1] 277568 0
Government body
Name [1] 277568 0
National Centre for Immunisation Research and Survelliance
Address [1] 277568 0
The Children's Hospital at Westmead
Cnr Hawkesbury Rd & Hainsworth St, Westmead
NSW, 2145

Country [1] 277568 0

Ethics approval
Ethics application status
Ethics committee name [1] 289705 0
Ethics committee address [1] 289705 0
Research Business Unit
Northern Sydney Local Health District
Level 13 Kollings Building
Royal North Shore Hospital
Pacific Highway
St Leonards, NSW 2065
Ethics committee country [1] 289705 0
Date submitted for ethics approval [1] 289705 0
Approval date [1] 289705 0
Ethics approval number [1] 289705 0

Brief summary
The cocooning strategy, which was implemented in Australia in 2009, can have a strong protective effect (indirect) against pertussis in infants. To achieve high maternal coverage, understanding maternal attitudes and other potentially influential factors is important. In this study, we examined the influence of baseline attitudes, modifiable factors and health message framing on pertussis booster vaccine uptake among postpartum women in the public hospital setting.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 42058 0
A/Prof John Sinn
Address 42058 0
Department of Neonatology level 5 Douglas Building Royal North Shore Hospital Pacific Highway, St Leonards, NSW, 2065
Country 42058 0
Phone 42058 0
Fax 42058 0
Email 42058 0
Contact person for public queries
Name 42059 0
Miss Elizabeth Hayles
Address 42059 0
Department of Neonatology level 5 Douglas Building Royal North Shore Hospital Pacific Highway, St Leonards, NSW, 2065
Country 42059 0
Phone 42059 0
Fax 42059 0
Email 42059 0
Contact person for scientific queries
Name 42060 0
Miss Elizabeth Hayles
Address 42060 0
Department of Neonatology level 5 Douglas Building Royal North Shore Hospital Pacific Highway, St Leonards, NSW, 2065
Country 42060 0
Phone 42060 0
Fax 42060 0
Email 42060 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary