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临床试验/NCT03603236
NCT03603236Unknown不适用

Evaluation of the Possible Relationship Between Preeclampsia and Periodontal Disease With Clinical Periodontal, Biochemical and Microbiological Data

Recep Tayyip Erdogan University Training and Research Hospital5 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2018年2月17日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
5
主要终点
prostaglandin E2

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 preeclampsia.

The secondary objective of the study is to analyze the relationship between preeclampsia and periodontal infection, using clinical, biochemical and microbiological methods.

详细描述

Preeclampsia is identified as an important cause for mother and newborn mortality. Inspite of extensive research, the exact etiological relations have not been established.

Periodontal disease is a subclinical and persistent infection source which induces the systemic inflammatory reactions and increases the risk of preeclampsia. It is believed that the results will set light to the etiology of preeclampsia 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

入选标准

  • pregnant women with preeclampsia
  • 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

prostaglandin E2

时间窗: 1 Day

prostaglandin E2 levels will be evaulated in salivary, serum and placenta samples using ELISA test Normal value:29-97 pg / ml

IL-1beta (Interleukin 1 beta)

时间窗: 1 day

IL-1beta levels will be evaulated in salivary, serum and placenta samples using ELISA test Normal value:3-227pg/ml

TNF-Alpha (Tumor necrosis factor -Alpha)

时间窗: 1 day

TNF-Alpha levels will be evaulated in salivary, serum and placenta samples using ELISA test Normal value:42-203pg/ml

次要结局

  • Tannerella Forsythia(1 Day)
  • Porphyromonas gingivalis(1 Day)

研究者

发起方
Recep Tayyip Erdogan University Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gul Yildiz Telatar

Principal Investigator

Recep Tayyip Erdogan University Training and Research Hospital

研究点 (5)

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