Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000767606
Ethics application status
Not required
Date submitted
18/10/2005
Date registered
28/11/2005
Date last updated
21/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving oral hygiene to reduce the risk of preterm birth: A randomised controlled trial
Scientific title
Improving oral hygiene to reduce the risk of preterm birth: A randomised controlled trial assessing a high intensity educational intervention
Secondary ID [1] 288389 0
No secondary ID
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
N/A 923 0
Condition category
Condition code
Reproductive Health and Childbirth 990 990 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Educational intervention during the antenatal period to improve oral hygiene.
Intervention code [1] 725 0
Prevention
Comparator / control treatment
Standard care during antenatal period to improve oral hygeine
Control group
Placebo

Outcomes
Primary outcome [1] 1316 0
Reduction in risk of preterm birth
Timepoint [1] 1316 0
Measured at birth
Secondary outcome [1] 2356 0
Adverse outcomes for the woman
Timepoint [1] 2356 0
No changes have been made
Secondary outcome [2] 2357 0
Maternal emotional wellbeing
Timepoint [2] 2357 0
No changes have been made
Secondary outcome [3] 2358 0
Adverse outcomes for the infant
Timepoint [3] 2358 0
No changes have been made

Eligibility
Key inclusion criteria
Singleton pregnancy.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Multiple pregnancy, active labour, or known fetal anomaly.

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)
Central telephone randomisation service
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random number sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2256
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 1087 0
Other
Name [1] 1087 0
Women's & Children's Hospital
Country [1] 1087 0
Australia
Primary sponsor type
Hospital
Name
The Women's & Children's Hospital, Adelaide
Address
72 King William Rd
North Adelaide SA 5006
Country
Australia
Secondary sponsor category [1] 948 0
None
Name [1] 948 0
N/A
Address [1] 948 0
Country [1] 948 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 2391 0
Women's and Children's Hospital
Ethics committee address [1] 2391 0
Ethics committee country [1] 2391 0
Australia
Date submitted for ethics approval [1] 2391 0
Approval date [1] 2391 0
Ethics approval number [1] 2391 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36111 0
Prof Caroline Crowther
Address 36111 0
Women's & Children's Hospital
72 King William Rd
North Adelaide SA 5006
Country 36111 0
Australia
Phone 36111 0
+61 8 8161 7619
Fax 36111 0
Email 36111 0
caroline.crowther@adelaide.edu.au
Contact person for public queries
Name 9914 0
Caroline Crowther
Address 9914 0
Department of Obstetrics & Gynaecology
The University of Adelaide
Women's and Children's Hospital
King William Road
North Adelaide SA 5006
Country 9914 0
Australia
Phone 9914 0
+61 8 81617647
Fax 9914 0
+61 8 81617652
Email 9914 0
caroline.crowther@adelaide.edu.au
Contact person for scientific queries
Name 842 0
Caroline Crowther
Address 842 0
Department of Obstetrics & Gynaecology
The University of Adelaide
Women's and Children's Hospital
King William Road
North Adelaide SA 5006
Country 842 0
Australia
Phone 842 0
+61 8 81617647
Fax 842 0
+61 8 81617652
Email 842 0
caroline.crowther@adelaide.edu.au

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.