Trial from ANZCTR


Trial ID ACTRN12609001052224
Trial Status: Registered
Date Submitted: 19/07/2008
Date Registered: 9/12/2009
Retrospectively registered

Page 1

Public title Screening for and treatment of asymptomatic candidiasis to prevent preterm birth: A pilot study
Update:
 
Reason:
 
Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format In pregnant women with asymptomatic candidiasis does treatment with clotrimozole compared with no treatment reduce the incidence of preterm birth?
Update:
 
Reason:
 
Secondary ID [1] 1185 0
Nil
Update:
 
Reason:
 
UTN
Update:
 
Reason:
 
Trial acronym CiPS
Update:
 

Page 2

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

Page 3

Descriptions of intervention(s) / exposure 1% Clotrimozole vaginal cream dispensed in a 35 gram tube with 6 single use disposable applicators for daily use for 6 days (~ 5 grams per day)
Update:
 
Reason:
 
Intervention Code:
Prevention 3156 0
Update:
 
Reason:
 
Intervention Code:
Treatment: drugs 255629 0
Update:
 
Reason:
 
Comparator / control treatment No treatment
This is a 2-arm trial
Update:
 
Reason:
 
Control group Active
Update:
 
Reason:
 

Page 4

Primary Outcome: Preterm birth less than 37 weeks 4482 0
Update:
 
Reason:
 
Timepoint: At birth 4482 0
Update:
 
Reason:
 
Secondary Outcome: Admission to Neonatal Intensive Care Unit 7582 0
Update:
 
Reason:
 
Timepoint: Up to first 28 days of life 7582 0
Update:
 
Reason:
 

Page 5

Key inclusion criteria Asymptomatic candidiasis
Singleton Pregnancy
Before 20 weeks gestation
Update:
 
Reason:
 
Minimum age 15 Years
Update:
 
Reason:
 
Update:
 
Reason:
 
Maximum age No limit
Update:
 
Reason:
 
Update:
 
Reason:
 
Gender Females
Update:
 
Reason:
 
Healthy volunteers? Yes
Update:
 
Reason:
 
Key exclusion criteria Multiple Pregnancy,
Symptomatic vaginal infection
Update:
 
Reason:
 

Page 6

Study type Interventional
Update:
 
Reason:
 
Purpose of the study Prevention
Update:
 
Allocation to intervention Randomised controlled trial
Update:
 
Reason:
 
Describe the 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. Women will either return to collect their allocated study treatment from the hospital pharmacy or it will be sent by mail, whichever is more convenient.
Update:
 
Reason:
 
Describe the 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.
Update:
 
Reason:
 
Masking / blinding Open (masking not used)
Update:
 
Reason:
 
Who is / are masked / blinded (choose all that apply)


Update:
       
Reason:
 
Assignment Parallel
Update:
 
Reason:
 
Other design features
Update:
 
Reason:
 
Type of endpoint(s) Efficacy
Update:
 
Reason:
 
Statistical Methods/Analysis
Update:
 
Reason:
 

Page 7

Phase Phase 4
Update:
 
Reason:
 
Anticipated date of first participant enrolment 12/06/2008
Update:
 
Reason:
 
Date of first participant enrolment
Update:
 
Reason:
 
Anticipated date last participant recruited/enrolled
Update:
 
Reason:
 
Actual date last participant recruited/enrolled
Update:
 
Reason:
 
Target sample size 500
Update:
 
Reason:
 
Recruitment status Recruiting
Update:
 
Reason:
 

Recruitment in Australia

Recruitment state(s)
Update:
 
Reason:
 

Recruitment outside Australia

Page 8

Funding Source: Hospital 3612 0
Update:
 
Reason:
 
Name: Royal North Shore Hospital 3612 0
Update:
 
Reason:
 
Address: St Leonards
NSW 2065
3612 0
Update:
 
Reason:
 
Country: Australia 3612 0
Update:
 
Reason:
 
Primary Sponsor Hospital
Update:
 
Reason:
 
Name: Royal North Shore Hospital
Update:
 
Reason:
 
Address: St Leonards
NSW 2065
Update:
 
Reason:
 
Country: Australia
Update:
 
Reason:
 
Secondary Sponsor: None 3245 0
Update:
 
Reason:
 
Name: 3245 0
Update:
 
Reason:
 
Address: 3245 0
Update:
 
Reason:
 
Country: 3245 0
Update:
 
Reason:
 

Page 9

Has the study received approval from at least one Ethics Committee? Yes
Update:
 
Reason:
 
Ethics Committee name: Northern Sydney and Central Coast Health (NSCCH) 5659 0
Update:
 
Reason:
 
Address: Royal North Shore Hospital
St Leonards
NSW 2065
5659 0
Update:
 
Reason:
 
Country: Australia 5659 0
Update:
 
Reason:
 
Approval Date: 5659 0
Update:
 
Reason:
 
Submitted Date: 01/06/2007 5659 0
Update:
 
Reason:
 
HREC: 0708-162M 5659 0
Update:
 
Reason:
 
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?'
Update:
 
Reason:
 
Trial website
Update:
 
Trial related presentations / publications
Update:
 
Public Notes
Update:
 

Page 10

Principal Investigator
Title:
Update:
 
Reason:
 
28764 0
Name:
Update:
 
Reason:
 
28764 0
Address:
Update:
 
Reason:
 
28764 0
Country:
Update:
 
28764 0
Reason:
 
Tel:
Update:
 
Reason:
 
28764 0
Fax:
Update:
 
Reason:
 
28764 0
Email:
Update:
 
Reason:
 
28764 0
Contact person for public queries
Title:
Update:
 
Reason:
 
11921 0
Name: Jonathan Morris
Update:
 
Reason:
 
11921 0
Address: Dept Obstetrics and Gynaecology Royal North shore Hospital Building 52 St Leonards NSW 2065
Update:
 
Reason:
 
11921 0
Country: Australia
Update:
 
11921 0
Reason:
 
Tel: +61 2 9926 7013
Update:
 
Reason:
 
11921 0
Fax: +61 2 9906 6742
Update:
 
Reason:
 
11921 0
Email: jmorris@med.usyd.edu.au
Update:
 
Reason:
 
11921 0

Contact person for scientific queries
Title:
Update:
 
Reason:
 
2849 0
Name: Jonathan Morris
Update:
 
Reason:
 
2849 0
Address: Dept Obstetrics and Gynaecology Royal North shore Hospital Building 52 St Leonards NSW 2065
Update:
 
Reason:
 
2849 0
Country: Australia
Update:
 
2849 0
Reason:
 
Tel: +61 2 9926 7013
Update:
 
Reason:
 
2849 0
Fax: +61 2 9906 6742
Update:
 
Reason:
 
2849 0
Email: jmorris@med.usyd.edu.au
Update:
 
Reason:
 
2849 0

Contact person responsible for updating information
Title:
Update:
 
Reason:
 
20993 0
Name: Jonathan Morris
Update:
 
Reason:
 
20993 0
Address: Dept Obstetrics and Gynaecology Royal North shore Hospital Building 52 St Leonards NSW 2065
Update:
 
Reason:
 
20993 0
Country: Australia
Update:
 
20993 0
Reason:
 
Tel: +61 2 9926 7013
Update:
 
Reason:
 
20993 0
Fax: +61 2 9906 6742
Update:
 
Reason:
 
20993 0
Email: jmorris@med.usyd.edu.au
Update:
 
Reason:
 
20993 0
   

Addition Cancer fields
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason: