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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
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.
Secondary ID [1] 262825 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Group B Streptococcal (GBS) colonisation in pregnant women 270548 0
Condition category
Condition code
Infection 270706 270706 0 0
Studies of infection and infectious agents
Reproductive Health and Childbirth 270716 270716 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 269175 0
Early detection / Screening
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)
Control group
Active

Outcomes
Primary outcome [1] 269421 0
Pain score for collection of the swabs, on a 5 point Likert scale (Pain-free, Minor discomfort, Moderate pain, Very painful, Unbearable)
Timepoint [1] 269421 0
At the time of collecting the swabs
Secondary outcome [1] 287595 0
Acceptability for collection of the swabs, on a 5 point Likert scale (Totally acceptable, Somewhat acceptable, Acceptable, Not acceptable, Not at all acceptable)
Timepoint [1] 287595 0
At the time of collecting the swabs
Secondary outcome [2] 287596 0
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.
Timepoint [2] 287596 0
At the time of collecting the swabs

Eligibility
Key inclusion criteria
Pregnant women at 35-37 weeks gestation
Planning vaginal delivery
Minimum age
No limit
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Planning elective Caesarean delivery

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
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.
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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4353 0
4560

Funding & Sponsors
Funding source category [1] 269649 0
Charities/Societies/Foundations
Name [1] 269649 0
RANZCOG Research Foundation
Address [1] 269649 0
College House
254 - 260 Albert St
East Melbourne
Victoria 3002
Country [1] 269649 0
Australia
Primary sponsor type
Hospital
Name
Nambour General Hospital
Address
Hospital Road
Nambour
Queensland 4560
Country
Australia
Secondary sponsor category [1] 266681 0
Individual
Name [1] 266681 0
Dr Kenneth Law
Address [1] 266681 0
Royal Hospital For Women
Barker Street
Randwick
NSW 2031
Country [1] 266681 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269597 0
Ethics committee address [1] 269597 0
Hospital Road
Nambour
Queensland 4560
Ethics committee country [1] 269597 0
Australia
Date submitted for ethics approval [1] 269597 0
11/05/2008
Approval date [1] 269597 0
31/07/2008
Ethics approval number [1] 269597 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33010 0
Address 33010 0
Country 33010 0
Phone 33010 0
Fax 33010 0
Email 33010 0
Contact person for public queries
Name 16257 0
Dr Kenneth Law
Address 16257 0
Royal Hospital for Women
Barker Street
Randwick
NSW 2031
Country 16257 0
Australia
Phone 16257 0
+61393826111
Fax 16257 0
Email 16257 0
kenneth.law@unsw.edu.au
Contact person for scientific queries
Name 7185 0
Dr Kenneth Law
Address 7185 0
Royal Hospital for Women
Barker Street
Randwick
NSW 2031
Country 7185 0
Australia
Phone 7185 0
+61393826111
Fax 7185 0
Email 7185 0
kenneth.law@unsw.edu.au

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