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临床试验/NCT00116974
NCT00116974终止3 期

Periodontal Infection and Prematurity Study

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 2,100 人开始时间: 2004年10月最近更新:
适应症

试验速览

阶段
3 期
状态
终止
入组人数
2,100
试验地点
2
主要终点
Whether screening and treating periodontal disease using scaling and root planing early in pregnancy can reduce the incidence of spontaneous preterm birth <35 weeks

研究概览

简要总结

This research project is a multi-center double-blind, parallel, randomized, controlled clinical trial design comparing the efficacy of dental scaling and root planing to control treatment (superficial cleaning) for the prevention of preterm birth in pregnant women with periodontal disease.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Gestational age between 6 and 20 completed weeks

排除标准

  • Periodontal treatment during the pregnancy
  • Antibiotic use within 2 weeks of enrollment
  • Use of antimicrobial mouthwash within 2 weeks
  • Multiple gestation
  • Known mitral valve prolapse

结局指标

主要结局

Whether screening and treating periodontal disease using scaling and root planing early in pregnancy can reduce the incidence of spontaneous preterm birth <35 weeks

时间窗: 9 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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