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临床试验/NCT02704676
NCT02704676Unknown不适用

CA-125 and Severity of Pre-Eclampsia

Ain Shams Maternity Hospital0 个研究点目标入组 120 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
主要终点
increase serum CA-125 in pre-eclamptic patients

研究概览

简要总结

The Aim of this study is to determine the relationship between serum concentrations of cancer antigen-125 (CA-125) and pre-eclampsia severity.

详细描述

Although the source of CA-125 during pregnancy is the fetal chorion, amniotic fluid, and maternal decidua, the perinatal dynamics of maternal serum CA-125 requires clarification. Clinical studies of CA-125 levels and its function in hypertensive pregnant patients are limited and offered contradictory results (Cebesoy et al., 2009).

And so we investigate CA-125 in normal pregnancy and in pre-eclampsia, comparing mild and sever pre-eclampsia to determine relationship of CA-125 and severity of the disease.

Patients will be divided in three groups:

  • Control: 40 normal healthy pregnant women attending the ER in labor.

  • Mild pre-eclampsia: 40 patients fulfilling the following criteria.

  • Blood pressure: systolic blood pressure >140 and <160 , Diastolic blood pressure >90 and <110

  • Proteinuria: 300 mg (+) assessed by urine urignost 3A® (urine strips from DIALAB).

  • No symptoms of severity as headache.

  • Normal investigations for different organ function (as liver and kidney function).

  • Severe pre-eclampsia :40 patients fulfilling anyone or more of the following criteria (The American College of Obstetricians and Gynecologists, 2010)(ACOG):

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Other causes elevate CA-125 as: ovarian cancer, endometrial cancer, breast cancer and benign conditions as: endometriosis and liver cirrhosis.
  • Chronic hypertension
  • Diabetes Mellitus (DM)
  • Liver diseases
  • Thyroid disorders
  • Kidney diseases
  • Cardiac diseases

结局指标

主要结局

increase serum CA-125 in pre-eclamptic patients

时间窗: 1 year

measuring serum CA-125

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mohamed Bahaa Eldin Ahmed

Clinical professor

Ain Shams Maternity Hospital

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