Role of Cytokines in Association Between Periodontitis and Preeclampsia During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 528
- 试验地点
- 1
- 主要终点
- Association between preeclampsia and periodontal disease and its correlation with the variation in cytokine levels.
研究概览
简要总结
Infections affecting the mother during pregnancy may produce alterations in the normal cytokine and hormone-regulated gestation, which could result in preeclampsia, preterm labor, premature rupture of membranes, and preterm birth. Therefore, pregnant women with periodontal disease may show an alteration in the cytokine levels which may cause preeclampsia in them.
详细描述
The enrolled subjects will be evaluated on the basis of a pre-designed and pre-tested proforma with respect to history and clinical examination, obstetrics examination and ultrasonography. The periodontal examination consists of assessments at vestibular, lingual, mesial and distal sites of all present teeth.Five ml venous blood sample will be drawn from the patient at the time of enrollment before 20 weeks of gestation for the levels of cytokines (IL-4, IL-10, IFN-g and TNF-α. All the subjects will be followed- up till delivery. At the time of delivery, the details of pregnancy outcome (maternal and fetal) along with the measurement of the blood pressure will be recorded. A repeat of oral health evaluation will be done within 48 hours of delivery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton live pregnancy.
- •Sure of her dates. (known dates of the last menstrual period)
- •Age group 18-35 years.
排除标准
- •Chronic hypertension
- •Polyhydramnios
- •Congenital malformation in fetus
- •Renal disease
- •Cardiovascular disease
- •Urolithiasis
- •Parathyroid disease
- •Systolic blood pressure measurement of more than 140mm Hg and diastolic blood pressure more than 90 mm Hg at first visit.
- •Infections (bacterial vaginosis and chorioamnionitis)
- •Antibiotic use during pregnancy
- •Excessive body mass index
- •Less than 20 natural teeth
结局指标
主要结局
Association between preeclampsia and periodontal disease and its correlation with the variation in cytokine levels.
时间窗: 3 years
次要结局
- Correlation of relationship of periodontal disease with preeclampsia and pregnancy outcome.(3 years)
研究者
Ashok Kumar
Director Professor
Maulana Azad Medical College