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Trial registered on ANZCTR


Trial ID
ACTRN12609001052224
Ethics application status
Approved
Date submitted
19/07/2008
Date registered
9/12/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Screening for and treatment of asymptomatic candidiasis to prevent preterm birth: A pilot study
Scientific title
In pregnant women with asymptomatic candidiasis does treatment with clotrimozole compared with no treatment reduce the incidence of preterm birth?
Secondary ID [1] 1185 0
Nil
Universal Trial Number (UTN)
Trial acronym
CiPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm birth 3425 0
Condition category
Condition code
Reproductive Health and Childbirth 3579 3579 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Clotrimazole 100mg pessaries for 6 days. This change was made prior to commencement of the pilot study. Amendment to protocol submitted and approved by HREC.
Intervention code [1] 3156 0
Prevention
Intervention code [2] 255629 0
Treatment: drugs
Comparator / control treatment
No treatment
This is a 2-arm trial
Control group
Active

Outcomes
Primary outcome [1] 4482 0
Preterm birth less than 37 weeks
Timepoint [1] 4482 0
At birth
Secondary outcome [1] 7582 0
Admission to Neonatal Intensive Care Unit
Timepoint [1] 7582 0
Up to first 28 days of life

Eligibility
Key inclusion criteria
Asymptomatic candidiasis
Singleton Pregnancy
Before 20 weeks gestation
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Multiple Pregnancy,
Symptomatic vaginal infection

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
In the pilot study, a research midwife will ask women to participate in the study, explain the trial and obtain informed consent. Women who provide consent will self collect a vaginal swab which will be cultured for candida. Those women who have candida isolated from their vaginal swab will be allocated to treatment or no treatment by central telephone randomisation. The randomisation schedule will be prepared by a researcher not involved with treatment allocation, and will use an equal allocation ratio in blocks of ten. Allocation will be via sealed opaque envelopes. Women randomised to the treatment arm will either return to collect their allocated study treatment from the hospital pharmacy or it will be sent by mail, whichever is more convenient.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be prepared by a researcher not involved with treatment allocation, using a computer random number generator.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy

Recruitment
Recruitment status
Completed
Anticipated date of first participant enrolment
12/06/2008
Actual date of first participant enrolment
12/06/2008
Anticipated date last participant enrolled
Actual date last participant enrolled
18/12/2009
Anticipated date of last data collection
Actual date of last data collection
30/06/2010
Target sample size
500
Actual sample size
500
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6352 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 13898 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 3612 0
Hospital
Name [1] 3612 0
Royal North Shore Hospital
Address [1] 3612 0
St Leonards
NSW 2065
Country [1] 3612 0
Australia
Primary sponsor type
Hospital
Name
Royal North Shore Hospital
Address
St Leonards
NSW 2065
Country
Australia
Secondary sponsor category [1] 3245 0
None
Name [1] 3245 0
Address [1] 3245 0
Country [1] 3245 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5659 0
Northern Sydney and Central Coast Health (NSCCH)
Ethics committee address [1] 5659 0
Royal North Shore Hospital
St Leonards
NSW 2065
Ethics committee country [1] 5659 0
Australia
Date submitted for ethics approval [1] 5659 0
01/06/2007
Approval date [1] 5659 0
29/05/2008
Ethics approval number [1] 5659 0
0708-162M

Summary
Brief summary
This is a pilot study to assess the fesaibility of a larger study aimed at answering the clinical question: 'In pregnant women with asymptomatic candidiasis does treatment reduce the incidence of preterm birth?'
Trial website
Trial related presentations / publications
Treatment of asymptomatic vaginal candidiasis in pregnancy to prevent preterm birth: an openlabel pilot randomized controlled trial
Christine L Roberts*, Kristen Rickard, George Kotsiou, Jonathan M Morris
Roberts et al. BMC Pregnancy and Childbirth 2011, 11:18
http://www.biomedcentral.com/1471-2393/11/18
Public notes

Contacts
Principal investigator
Name 28764 0
Prof Jonathan Morris
Address 28764 0
Level 13 Kolling Building, Royal North Shore Hospital, St Leoanrds NSW 2065
Country 28764 0
Australia
Phone 28764 0
+61 2 99264731
Fax 28764 0
Email 28764 0
jonathan.morris@sydney.edu.au
Contact person for public queries
Name 11921 0
Prof Jonathan Morris
Address 11921 0
Dept Obstetrics and Gynaecology
Royal North shore Hospital
Building 52
St Leonards NSW 2065
Country 11921 0
Australia
Phone 11921 0
+61 2 9926 7013
Fax 11921 0
+61 2 9906 6742
Email 11921 0
jmorris@med.usyd.edu.au
Contact person for scientific queries
Name 2849 0
Prof Jonathan Morris
Address 2849 0
Dept Obstetrics and Gynaecology
Royal North shore Hospital
Building 52
St Leonards NSW 2065
Country 2849 0
Australia
Phone 2849 0
+61 2 9926 7013
Fax 2849 0
+61 2 9906 6742
Email 2849 0
jmorris@med.usyd.edu.au