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Trial registered on ANZCTR
Registration number
ACTRN12611000863932
Ethics application status
Approved
Date submitted
12/08/2011
Date registered
15/08/2011
Date last updated
10/10/2011
Type of registration
Retrospectively registered
Titles & IDs
Public title
A comparative study assessing the efficacy and acceptability of anorectal swabs for antenatal Group B Streptococcus (GBS) screening
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Scientific title
Low vaginal swabs versus Anorectal swabs for antenatal screening for Group B Streptococcus in Australian women at 35 to 37 weeks gestation, assessing the detection rate and pain/acceptability scores of the two swabs.
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Secondary ID [1]
262825
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Group B Streptococcal (GBS) colonisation in pregnant women
270548
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Condition category
Condition code
Infection
270706
270706
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0
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Studies of infection and infectious agents
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Reproductive Health and Childbirth
270716
270716
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0
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Antenatal care
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Anorectal swab (ARS) for GBS, taken once only at 35-37 weeks gestation, immediately after taking the Low vagina swab (at the same session). All women undergo both the anorectal swab and low vaginal swab.
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Intervention code [1]
269175
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Early detection / Screening
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Comparator / control treatment
Low vaginal swab (LVS) for GBS, taken once only at 35-37 weeks gestation, immediately before taking the Anorectal swab (at the same session)
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Control group
Active
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Outcomes
Primary outcome [1]
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Pain score for collection of the swabs, on a 5 point Likert scale (Pain-free, Minor discomfort, Moderate pain, Very painful, Unbearable)
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Assessment method [1]
269421
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Timepoint [1]
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At the time of collecting the swabs
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Secondary outcome [1]
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Acceptability for collection of the swabs, on a 5 point Likert scale (Totally acceptable, Somewhat acceptable, Acceptable, Not acceptable, Not at all acceptable)
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Assessment method [1]
287595
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Timepoint [1]
287595
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At the time of collecting the swabs
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Secondary outcome [2]
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Positivity rate of the LVS and ARS for GBS. The swabs are analysed by microbiological culture in an approved and accredited microbiological laboratory, and the results are reported electronically as either positive or negative for GBS.
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Assessment method [2]
287596
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Timepoint [2]
287596
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At the time of collecting the swabs
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Eligibility
Key inclusion criteria
Pregnant women at 35-37 weeks gestation
Planning vaginal delivery
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Minimum age
No limit
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Planning elective Caesarean delivery
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Women who are planning for a vaginal delivery are enrolled into the study at 35-37 weeks gestation. All subjects undergo the same intervention (LVS and ARS), and therefore there is no allocation of treatment or concealment procedures.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No randomisation is required, as all subjects undergo the same intervention (LVS and ARS)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
4/08/2008
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment postcode(s) [1]
4353
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4560
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Funding & Sponsors
Funding source category [1]
269649
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Charities/Societies/Foundations
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Name [1]
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RANZCOG Research Foundation
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Address [1]
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College House
254 - 260 Albert St
East Melbourne
Victoria 3002
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Country [1]
269649
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Australia
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Primary sponsor type
Hospital
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Name
Nambour General Hospital
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Address
Hospital Road
Nambour
Queensland 4560
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
266681
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Dr Kenneth Law
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Address [1]
266681
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Royal Hospital For Women
Barker Street
Randwick
NSW 2031
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Country [1]
266681
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
269597
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Ethics committee address [1]
269597
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Hospital Road
Nambour
Queensland 4560
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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11/05/2008
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Approval date [1]
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31/07/2008
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Ethics approval number [1]
269597
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Summary
Brief summary
For antenatal screening for Group B Streptococcus (GBS), current guidelines from the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) recommend both a low vaginal swab (LVS) and an anorectal swab (ARS) to be taken. The addition of an ARS to a LVS is reported to increase the GBS detection rate compared to performing a LVS alone. Despite these recommendations, many clinicians perform a LVS alone for GBS screening, and patient and physician acceptability may be responsible. We aim to assess the pain and acceptability of the LVS and ARS, and the detection rate for GBS from each swab.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
33010
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Address
33010
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Country
33010
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Phone
33010
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Fax
33010
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Email
33010
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Contact person for public queries
Name
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Dr Kenneth Law
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Address
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Royal Hospital for Women
Barker Street
Randwick
NSW 2031
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Country
16257
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Australia
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Phone
16257
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+61393826111
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Fax
16257
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Email
16257
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[email protected]
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Contact person for scientific queries
Name
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Dr Kenneth Law
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Address
7185
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Royal Hospital for Women
Barker Street
Randwick
NSW 2031
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Country
7185
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Australia
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Phone
7185
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+61393826111
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Fax
7185
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Email
7185
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[email protected]
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No information has been provided regarding IPD availability
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.
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