Evaluation of the Possible Relationship Between Preterm Labor and Periodontal Disease With Clinical Periodontal, Biochemical and Microbiological Data
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- TNF-Alpha
研究概览
简要总结
The primary objective of the study is to assess the incidence and severity of the periodontal infection of patients with preterm labor.
The secondary objective of the study is to analyze the relationship between preterm labor and periodontal infection, using clinical, biochemical and microbiological methods.
详细描述
Preterm infants are born prior to completion of 37 weeks of gestation. Periodontal disease is a subclinical and persistent infection source which induces the systemic inflammatory reactions and increases the risk of preterm labor. It is believed that the results will set light to the etiology of preterm labor and will help to develop strategies to prevent the disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 34 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant women with preterm labor
- •weeks of pregnant women with no history of preterm labor
排除标准
- •Genitourinary infection
- •pregnancy or pre-pregnancy hypertension
- •HIV infection
- •diabetes mellitus
- •multiple pregnancy, preterm labor / low birth weight
- •smoker and alcohol use history
- •IVF pregnancy
- •placental, cervical and uterine anomalies
- •pregnancy with intrauterine growth retardation
- •pregnancies with congenital or chromosomal fetal anomalies
- •significant vaginal bleeding
- •infertility stories
- •drug addicts
- •poor socioeconomic level
结局指标
主要结局
TNF-Alpha
时间窗: 1 day
TNF-Alpha levels will be evaluated in salivary, serum and placenta samples using ELISA test Normal value:42-203pg/ml
prostaglandin E2
时间窗: 1 Day
prostaglandin E2 levels will be evaluated in salivary, serum and placenta samples using ELISA test Normal value:29-97 pg / ml
IL-1beta
时间窗: 1 day
IL-1beta levels will be evaluated in salivary, serum and placenta samples using ELISA test Normal value:3-227pg/ml
次要结局
- Porphyromonas gingivalis(1 Day)
- Tannerella Forsythia(1 Day)
研究者
Gul Yildiz Telatar
Principal Investigator
Recep Tayyip Erdogan University Training and Research Hospital