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临床试验/NCT02111148
NCT02111148Unknown不适用

Urea and Creatinine Versus Nitrazine Test in Vaginal Fluid Wash in Diagnosed Pre Labour Rupture of Membranes

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2014年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
105
试验地点
1
主要终点
Urea and creatinine in vaginal fluid

研究概览

简要总结

The investigators assess in this study the sensitivity of Urea and Creatinine and that of Nitrazine test in vaginal wash after injecting saline in the vagina of patients with pre-labour rupture of membranes

详细描述

The aim of this study is to compare the accuracy of measuring the urea and creatinine level versus that of nitrazine test in vaginal wash of pre-labour rupture of membranes patients.Each patient with rupture of membranes will be assessed clinically and then if not in labour , patients will be divided into 2 groups, 5ml saline will be injected in the vagina of each patient in every group then the vaginal wash will be collected in a test tube. Urea and creatinine group, biochemical tests for urea and creatinine in mIU/ml to detect their presence in the wash will be done. In Nitrazine group wash will be assessed by nitrazine paper showing bluish discoloration in rupture membranes. Sensitivity of each test in diagnosed rupture of membranes will be assessed.Which means how many patients in each test show positive results in case of diagnosed case.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
30 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Gestational age between 28 and 41 weeks
  • Single intrauterine pregnancy
  • History of gush of fluid
  • Liquor detected on speculum examination

排除标准

  • Vaginal bleeding
  • Patients in labour
  • Contaminated samples

研究组 & 干预措施

urea and creatinine

Active Comparator

urea and creatinine detected in vaginal fluid wash after injecting of 5 ml saline intavaginally

干预措施: Urea and creatinine (Procedure)

Nitrazine

Active Comparator

Biochemical description of Nitrazine in the vaginal wash

干预措施: Nitrazine (Procedure)

saline

Active Comparator

5ml saline will be injected in vagina of each patient in both groups within 24 hours of membrane rupture.

干预措施: 5ml saline (Drug)

结局指标

主要结局

Urea and creatinine in vaginal fluid

时间窗: Within first 24 hours after rupture of membranes in third trimester

5ml saline will be injected vaginally then vaginal fluid will be collected.

次要结局

  • Nitrazine test(Within first 24 hours after rupture of membranes in third trimester)

研究者

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

Nesreen Abdel Fattah Abdullah Shehata

Beni-Suef University

Beni-Suef University

研究点 (1)

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