NCT00133926Unknown2 期
Prevention of Pre-Term Birth by Treatment of Periodontal Disease During Pregnancy - The Smile Study
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 1,094
- 试验地点
- 2
- 主要终点
- Rate of pre-term birth
研究概览
简要总结
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 pregnancy. Dental screening and periodontal treatment protocols have been based on standard techniques employed by hygienists that can be readily applied to the general obstetric population.
详细描述
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 during pregnancy reduces the rate of:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Rate of pre-term birth
次要结局
- Rate of fetal growth restriction
- Rate of pre-eclampsia
- Rate of complications of pre-term birth
研究者
研究点 (2)
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