Status:
UNKNOWN
Prevention of Pre-Term Birth by Treatment of Periodontal Disease
Lead Sponsor:
King Edward Memorial Hospital
Collaborating Sponsors:
The University of Western Australia
Conditions:
Periodontal Diseases
Premature Birth
Eligibility:
FEMALE
16+ years
Phase:
PHASE2
Brief Summary
The aim of the study is to investigate, in an Australian population of pregnant women, whether the treatment of periodontal disease during pregnancy prevents pre-term birth and other complications of ...
Detailed Description
HYPOTHESES Primary Hypothesis: That treatment of periodontal disease during pregnancy reduces the rate of pre-term birth from 12% to 7%. Secondary Hypothesis: That treatment of periodontal disease...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2008
Estimated Enrollment :
1094 Patients enrolled
Trial Details
Trial ID
NCT00133926
Start Date
March 1 2005
End Date
June 1 2008
Last Update
April 5 2007
Active Locations (1)
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1
King Edward Memorial Hospital, Bagot Rd, Subiaco
Perth, Western Australia, Australia, 6008