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临床试验/NCT04651309
NCT04651309已完成不适用

Assessment of Labour Progress by Intrapartum Ultrasound: Can it Reduce the Incidence of Chorioamnionitis?

Kaplan Medical Center2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2019年8月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
180
试验地点
2
主要终点
Fever and infection rates in each of the study arms

研究概览

简要总结

Assessment of labor progress via digital exams is considered the standard of care in most delivery rooms. However, this method can be stressful, painful and imprecise and multiple exams increase the risk for chorioamnionitis. Trans-perineal ultrasound (TPUS) was found to be an objective noninvasive way to monitor labor progress. The study aim is to investigate whether, in nulliparous women, the use of TPUS during labor can reduce the number of vaginal exams and the incidence of chorioamnionitis.

详细描述

The prevalence of chorioamnionitis in term deliveries is 1-5% and in preterm deliveries the numbers can be as high as 25%. Most infections are a result of an ascending infection of the normal vaginal flora. Among risk factors are nulliparity, rupture of membranes, an extended duration of labor, multiple vaginal examinations and GBS colonization.

The digital vaginal examination remains to this day the standard method for evaluating the patient's cervical status. However, this method is both highly subjective as well as painful and stressogenic for the patients.

In recent years there has been great progress in the field of translabial/transperineal sonography. There have been several studies which showed that this technique could be as useful as digital examinations in helping clinicians predict the course of labor. Recent studies demonstrate that using transperineal sonography can reduce the perception of pain compared with routine digital vaginal examinations. Even so, there has been little evidence as to whether using perineal ultrasound may also reduce peripartum and puerperal infections and if using sonography and refraining from digital examinations affects the course and duration of labor.

Our objective is to evaluate whether the incidence of chorioamnionitis or fever can be decreased. This goal would hopefully be achieved by assessing the progression of labor using mostly transperineal ultrasound, thus avoiding digital vaginal examination as much as possible.

The study would focus on primigravid women as they are known to be in a higher risk for infection and also other potential risk factors such as GBS carriers and PROM.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • Primigravida
  • Gestational age ≥ 37 weeks (according to 1st trimester sonography)
  • Single fetus •Cephalic presentation

排除标准

  • o Other known active infection (such as URTI, UTI)
  • Women who are taking immunosuppressive therapy
  • Women who arrived in active labor and delivered before being assessed by a physician.
  • Women with contra-indications for vaginal birth

结局指标

主要结局

Fever and infection rates in each of the study arms

时间窗: From admission to hospital for labor until 2 week post-partum

Intrapartum and post partum fever rates will be evaluated in both the study and the control groups.

Number of digital exams in each of the study arms

时间窗: From admission to hospital until delivery

The number of digital exams will be counted in each of the study arms

次要结局

未报告次要终点

研究者

发起方
Kaplan Medical Center
申办方类型
Other
责任方
Sponsor

研究点 (2)

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