跳至主要内容
临床试验/NCT03435965
NCT03435965Unknown不适用

Dilemma for Diagnosis of Amniotic Fluid Leakeage by AmnioQuickDuo+

Aljazeera Hospital2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年11月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
2
主要终点
number of participants who was diagnosed with leakage of liqour by AmnioQuickDuo+

研究概览

简要总结

Preterm premature rupture of the membranes (PPROM) is responsible for one-third of all preterm births. Optimum treatment relies on accurate diagnosis and gestational age. The diagnosis of PPROM is made by a combination of examination, patient history and some simple tests.

详细描述

Premature rupture of the fetal membranes (PROM) is the rupture of the amniotic membranes with release of the amniotic fluid prior to the onset of labour. PROM may be subdivided into term -PROM (TPROM, i.e. PROM after 37 weeks of gestation) and preterm PROM (PPROM, i.e. PROM prior to 37 weeks of gestation). PPROM occurs in approximately 3% of pregnancies and is responsible for a third of all preterm births.The diagnosis of PPROM is made by examination , patient history and simple testing. Patient history has an accuracy of 90% for the diagnosis of PPROM

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
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant ladies with PROM from 20- 37 weeks

排除标准

  • Gestational Age >37 wks Non reassuring CTG Signs of chorioamnonitis ( Fever , maternal or fetal tachycardia , Foul cervical discharge , uterine tenderness or high TLC ) Antepartum hemorrhage

结局指标

主要结局

number of participants who was diagnosed with leakage of liqour by AmnioQuickDuo+

时间窗: within a week

the accuracy of amnioQuick to diagnose PROM

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

Mahmoud Alalfy

Assistant Researcher , National Research centre and Specialist of Obstetrics and Gynecology in Aljazeerah hospital

Aljazeera Hospital

研究点 (2)

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