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临床试验/NCT03213535
NCT03213535Unknown不适用

Urea and Creatinine Level in Vaginal Fluid as a Predicator for Length of Latency Period in Prelabour Membranes Rupture

Ain Shams University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
delivery interval in Premature rupture of membranes

研究概览

简要总结

This study aims to investigate the relation between the concentration of urea and creatinine in vaginal fluid and length of latency period in women with PROM between 32 and 35 weeks gestation.

详细描述

60 pregnant women with PROM with singleton pregnancies with a gestational age between 32- 35 gestational weeks History taking followed by examination All women will be put in dorsal lithotomy position, using a proper light source and sterile gloves; sterile speculum free of gel will be placed into vagina.

For every woman a specimen of vaginal fluid will be taken as follows: 5 ml of sterile saline solution will be injected into the posterior vaginal fornix taken after aspiration of 3ml with the same syringe.

All samples will be obtained within 6 hours after membranes rupture before vaginal examination and the administration of any drugs. Upon collection, samples were centrifuged at 3000 rpm for 10 minutes and supernatant fluid was separated. Exact concentrations of urea and creatinine will be measured

All women will be put under observation for 48 hours and time of onset of delivery will be documented, the onset of labor will be diagnosed by either:

  1. Frequent uterine contractions more than 2 contractions in 10 minutes.
  2. CTG showing frequent contractions.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Maternal age between 20-35 years.
  • •32-35 weeks gestational age.
  • •Viable fetus.

排除标准

  • •Vaginal bleeding either spontaneous or traumatic e.g. placenta previa.
  • •Chorioamnionitis.
  • •Multiple pregnancy.
  • •Presence of uterine contractions.
  • •Amniotic fluid disorders e.g. polyhydramnios
  • •Meconium stained amniotic fluid prior to active phase of labor.
  • •Maternal disease necessitating termination of pregnancy e.g. severe preeclampsia

结局指标

主要结局

delivery interval in Premature rupture of membranes

时间窗: 48 hours

The time needed from the onset of PROM till time of onset of labour

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

rasha medhat abdul-hady

principal Investigator Dr.rasha medhat abdul-hady

Ain Shams University

研究点 (1)

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