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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00133926




Registration number
NCT00133926
Ethics application status
Date submitted
23/08/2005
Date registered
24/08/2005
Date last updated
5/04/2007

Titles & IDs
Public title
Prevention of Pre-Term Birth by Treatment of Periodontal Disease
Scientific title
Prevention of Pre-Term Birth by Treatment of Periodontal Disease During Pregnancy - The Smile Study
Secondary ID [1] 0 0
NHMRC Australia 353577
Secondary ID [2] 0 0
353577
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Periodontal Diseases 0 0
Premature Birth 0 0
Pre-Eclampsia 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 0 0 0 0
Other infectious diseases
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy
Cardiovascular 0 0 0 0
Hypertension
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of pre-term birth
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Rate of fetal growth restriction
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Rate of pre-eclampsia
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Rate of complications of pre-term birth
Timepoint [3] 0 0

Eligibility
Key inclusion criteria
* Pregnant women, with single pregnancies, between 12 and 20 weeks gestation
* Periodontal disease defined as periodontal pocketing at a threshold of 4mm or more at 10% or more of sites
* Agree to receive periodontal treatment
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Unable to attend for treatment
* Less than 16 years of age
* Have a fetus with an abnormality that predisposes the pregnancy to pre-term birth
* Multiple pregnancy
* Cardiac disease that would require antibiotic therapy
* Have fewer than 20 teeth
* Present for antenatal care after 20 weeks gestation
* Unable to understand the implications of participation in the trial
* Currently receiving periodontal treatment

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2008
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
King Edward Memorial Hospital, Bagot Rd, Subiaco - Perth
Recruitment postcode(s) [1] 0 0
6008 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
King Edward Memorial Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of Western Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
John P Newnham, MD, FRANZCOG
Address 0 0
The University of Western Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
John P Newnham, MD, FRANZCOG
Address 0 0
Country 0 0
Phone 0 0
61 9 9340 1331
Fax 0 0
Email 0 0
jnewnham@obsgyn.uwa.edu.au
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00133926