MOTOR: Maternal Oral Therapy to Reduce Obstetric Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,800
- 试验地点
- 2
- 主要终点
- Birth at less than 37 weeks gestational age
研究概览
简要总结
The purpose of this study is to determine whether maternal periodontal therapy (tooth cleaning) decreases the rate of preterm deliveries at <37 weeks gestation and to determine the effects of maternal periodontal therapy on the birth weight of infants born less than 37 weeks gestation.
详细描述
STUDY DESIGN:
The intervention is designed as a multi-center, randomized, controlled, clinical trial to determine the effects of periodontal therapy on the rate of preterm birth. Study participants will be assigned to one of two study arms. All pregnant women who present to the designated Obstetrical (OB) clinics are potential subjects for this study. A total of 1800 patients will be enrolled at 3 performance sites, enrolling about 600 subjects at each site at a rate of about 171 subjects/year at each site, randomly assigning these subjects to one of 2 treatment arms. Randomization will be performed using a computer-generated assignment scheme designed and performed in a masked manner by the data coordinating center. Each performance site will enroll about 300 subjects into each treatment group using the intent-to-treat principle, obtaining follow-up on all subjects. In treatment Group 1 participants will be assigned to standard localized periodontal therapy of scaling and root planning with subgingival polishing between three and six months of gestation. Group 2 will receive the same local periodontal therapy immediately following delivery.
MASKING:
The dental examiner will not be aware of the randomization treatment assignments of participants until after a complete baseline periodontal examination has been conducted. The study protocol allows the dental examiner to know the treatment assignment of participants but this knowledge will not affect the assessment of the primary obstetric outcome of the study. OB personnel or individuals collecting OB data will be masked as to dental treatments. At delivery the second dental exam will be made without the examiner knowing the pregnancy outcome.
PRIMARY/SECONDARY OUTCOME MEASURES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single
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
- 是
入选标准
- •Willing to be randomized and complete treatment protocols and provide informed consent
- •Planning on prenatal care and delivery at the enrollment center
- •Pregnant and able to complete periodontal treatment prior to 236 weeks gestation
- •At least 16 years old at enrollment
- •Minimum of 20 teeth present
- •Three (3) or more periodontal sites with > 3mm clinical attachment loss
排除标准
- •Multiple gestation
- •Positive history of HIV infection, AIDS, autoimmune disease, or diabetes (gestational diabetes is acceptable)
- •Any medical contraindication to periodontal probing or periodontal treatment that would require antibiotic prophylaxis, (e.g., congenital heart disease, use of Phen- fen for weight loss without a clear
研究组 & 干预措施
Periodontal Treatment
maternal periodontal therapy
干预措施: multi-center, randomized, controled periodontal therapy (Other)
结局指标
主要结局
Birth at less than 37 weeks gestational age
时间窗: 37 weeks gestational age
次要结局
未报告次要终点