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Trial registered on ANZCTR


Registration number
ACTRN12610000607077
Ethics application status
Approved
Date submitted
20/07/2010
Date registered
27/07/2010
Date last updated
15/11/2019
Date data sharing statement initially provided
2/11/2018
Date results information initially provided
2/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Treatment of asymptomatic candidiasis in pregnant women for the prevention of preterm birth: a randomised trial
Scientific title
Does treatment of asymptomatic candidiasis in pregnant women, with clotrimazole versus usual care, prevent preterm birth?
Secondary ID [1] 252202 0
National Health and Medical Research Council (NHMRC) Project Number 632544 and Grant number APP1078624
Universal Trial Number (UTN)
Trial acronym
CiPS (Candida in Pregnancy Study)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asymptomatic candidiasis 252325 0
Preterm birth 252326 0
Condition category
Condition code
Reproductive Health and Childbirth 252511 252511 0 0
Antenatal care
Reproductive Health and Childbirth 252512 252512 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Clotrimazole vaginal pessaries (100 mg) for daily use for 6 days. Women will be advised to insert one pessary as gently and deeply as possible into the vagina while lying on her back, preferably at night, for 6 nights.
Intervention code [1] 255630 0
Early detection / Screening
Intervention code [2] 255631 0
Prevention
Intervention code [3] 255632 0
Treatment: Drugs
Comparator / control treatment
Usual care (screening result is not revealed; routine antenatal care for the duration of pregnancy).
Screening for asymptomatic candidiasis involves self-collection of a vaginal swab.
Control group
Active

Outcomes
Primary outcome [1] 253398 0
1: Preterm birth between 20+0 to 36+6 weeks gestation following spontaneous onset of labour or following preterm prelabour rupture of membranes (PPROM).
http://hdl.handle.net/2123/15426
Timepoint [1] 253398 0
Birth
Secondary outcome [1] 262483 0
At birth any preterm birth, medically indicated preterm birth (including indication), preterm birth between 20+0 to 31+ 6 weeks, preterm prelabour rupture of the membranes, spontaneous pregnancy loss <20 weeks gestation, fetal growth restriction (<10th birthweight for gestational age percentile), birth weight, Apgar score at 5 minutes (an indicator of the health status of the newborn infant).
http://hdl.handle.net/2123/15426
Timepoint [1] 262483 0
At birth
Secondary outcome [2] 262489 0
Perinatal mortality (births > = 20+0 weeks resulting in either stillbirth or neonatal death)
Timepoint [2] 262489 0
< 29 days of life
Secondary outcome [3] 262490 0
Admission to neonatal intensive care unit
Timepoint [3] 262490 0
At final discharge following birth, obtained from existing computerised obstetric and hospital databases
Secondary outcome [4] 262491 0
Maternal length of stay (LOS) for delivery admission
Timepoint [4] 262491 0
At final discharge following birth, obtained from existing computerised obstetric and hospital databases
Secondary outcome [5] 264911 0
Neonatal length of stay (LOS)
Timepoint [5] 264911 0
At final discharge following birth, obtained from existing computerised obstetric and hospital databases
Secondary outcome [6] 264912 0
A composite neonatal morbidity indicator including respiratory distress, assisted ventilation, intraventricular haemorrhage, necrotising enterocolitis, retinopathy and pneumonia.
Lain et al, Maternal Child Health Journal 2012; 16(3): 600-8
Timepoint [6] 264912 0
At final discharge following birth, obtained from existing computerised obstetric and hospital databases
Secondary outcome [7] 326601 0
Symptoms of candidiasis, use of antibiotics and /or corticosteroids, treatment of candidiasis, compliance with the treatment regimen and treatment side effects.
Timepoint [7] 326601 0
Follow up survey sent at 28-32 weeks gestation
Secondary outcome [8] 326602 0
Pregnancy hypertension, gestational diabetes, antepartum haemorrhage, placental abnornmalities, fetal malformations, onset of labour, mode of delivery
Timepoint [8] 326602 0
Birth, obtained from from existing computerised obstetric and hospital databases

Eligibility
Key inclusion criteria
Pregnant women presenting for antenatal care between 12+0 and 19+6 weeks gestation with singleton pregnancies and asymptomatic candidiasis
Minimum age
No limit
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women: with symptomatic candidiasis, who present beyond 20 weeks gestation or have a history of hypersensitivity to clotrimazole

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)
Pregnant women will be recruited while attending a routine antenatal visit. The research nurse will ask eligible women to participate, explain the trial and obtain informed consent, collect baseline data and ask women to self-collect a vaginal swab. Women who are culture positive for Candida will be randomised to receive active treatment with clotrimazole or no treatment and the screening result is not revealed. The women randomised to clotrimazole treatment will be notified by phone by a research nurse. A central pharmacy will be responsible for dispensing the study medication which will be sent to participants by mail from the coordinating centre. This approach has been acceptable and successful in a pilot study.
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, and will use random permuted blocks and 1:1 randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
We will use a prospective, randomised, open-label, blinded-endpoint (PROBE) study design. Here (as in our pilot study) the strict randomisation and allocation concealment procedures are maintained but women will be randomised to open-label treatment (Canestan (Registerd Trademark)), or no treatment and the screening result is not revealed (consistent with current clinical practice).
Phase
Phase 4
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)
NSW
Recruitment hospital [1] 3338 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 3339 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 3340 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment hospital [4] 3341 0
St George Hospital - Kogarah
Recruitment hospital [5] 3342 0
Royal Hospital for Women - Randwick
Recruitment hospital [6] 3343 0
Liverpool Hospital - Liverpool
Recruitment hospital [7] 3344 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [8] 3345 0
Nepean Hospital - Kingswood
Recruitment hospital [9] 3346 0
Westmead Hospital - Westmead

Funding & Sponsors
Funding source category [1] 256115 0
Government body
Name [1] 256115 0
National Health & Medical Research Council
Address [1] 256115 0
GPO Box 1421
Canberra ACT 2601
Country [1] 256115 0
Australia
Primary sponsor type
Other
Name
Northern Sydney Central Coast Area Health Service
Address
Executive Office
Locked Bag 2915
Central Coast Business Centre
NSW 2252
Country
Australia
Secondary sponsor category [1] 251461 0
None
Name [1] 251461 0
Address [1] 251461 0
Country [1] 251461 0
Other collaborator category [1] 251385 0
Individual
Name [1] 251385 0
Christine Roberts
Address [1] 251385 0
Clinical and Population Perinatal Health Research
Building 52,
University of Sydney at Royal North Shore Hospital,
St Leonards 2065
Country [1] 251385 0
Australia
Other collaborator category [2] 251386 0
Individual
Name [2] 251386 0
Warwick Giles
Address [2] 251386 0
Dept of Obstetrics and Gynaecology,
Royal North Shore Hospital,
St Leonards 2065
Country [2] 251386 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258259 0
Northern Sydney Central Coast Area Health Service Human Research Ethics Committee
Ethics committee address [1] 258259 0
Level 13
Kolling Building
Royal North Shore Hospital,
Pacific Highway,
St Leonards
NSW 2065
Ethics committee country [1] 258259 0
Australia
Date submitted for ethics approval [1] 258259 0
Approval date [1] 258259 0
12/10/2009
Ethics approval number [1] 258259 0
0907-165M
Ethics committee name [2] 295697 0
NSW Population and Health Services Research Ethics Commitee
Ethics committee address [2] 295697 0
PO Box 41
Alexandria
NSW 1435
Ethics committee country [2] 295697 0
Australia
Date submitted for ethics approval [2] 295697 0
30/09/2014
Approval date [2] 295697 0
27/10/2014
Ethics approval number [2] 295697 0
HREC/14/CIPHS/62, Cancer Institute NSW Ref 2014/10/558

Summary
Brief summary
Being born too early is a leading cause of perinatal death and morbidity. This trial seeks to determine whether screening for and treating asymptomatic candidiasis in pregnancy reduces the risk of this serious health problem. The trial will discover whether a simple treatment in pregnancy can reduce preterm birth. If positive, the results will be relevant to the management of every pregnancy.
Trial website
N/A
Trial related presentations / publications
1. Roberts et al: Protocol for a randomised controlled trial of treatment of asymptomatic candidiasis for the prevention of preterm birth. BMC Pregnancy and Childbirth 2011,11:19
2. The Candida in Pregnancy Study (CiPS) Statistical Analysis Plan. http://hdl.handle.neet/2123/15426
Public notes

Contacts
Principal investigator
Name 30568 0
Prof Jonathan Morris
Address 30568 0
Level 5, Douglas Building, Royal North Shore Hospital, St Leonards NSW 2065
Country 30568 0
Australia
Phone 30568 0
+61 2 94629784
Fax 30568 0
Email 30568 0
jonathan.morris@sydney.edu.au
Contact person for public queries
Name 13815 0
Prof Jonathan Morris
Address 13815 0
Level 5, Douglas Building, Royal North Shore Hospital, St Leonards NSW 2065
Country 13815 0
Australia
Phone 13815 0
+61 2 94629784
Fax 13815 0
Email 13815 0
jonathan.morris@sydney.edu.au
Contact person for scientific queries
Name 4743 0
Prof Jonathan Morris
Address 4743 0
Level 5, Douglas Building, Royal North Shore Hospital, St Leonards NSW 2065
Country 4743 0
Australia
Phone 4743 0
+61 2 94629784
Fax 4743 0
Email 4743 0
jonathan.morris@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The investigators acknowledge, and concur with, the research community’s wish to publicly share trial data. Outcome data for this trial are obtained from routinely collected data that are maintained and administered by the Ministry of Health, with access predicated by the Ministry rules and regulations. To protect patient privacy, the ethics approval and data release requirements for this trial prohibit the trial researchers reporting or sharing individual patient data with other researchers, only summary data can be published or shared. Summary (aggregated) data can be provided to other researchers, as long as such data cannot result in identification of any individual patient. Any group wishing to access anonymised individual patient record data for research purposes must seek approval from the relevant Human Research Ethics Committees and, subject to ethical approval, the NSW Ministry of Health (for data release).
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary