跳至主要内容
临床试验/NCT02927730
NCT02927730已完成不适用

The Correlation Between Clinical Diagnosis of Retained Placenta And Histology

Bait Balev Hospital0 个研究点目标入组 240 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
240
主要终点
the correlation between clinical suspicion and histological diagnosis of retained placental tissue Finding is 67.5 %.

研究概览

简要总结

The main purpose is to evaluate the correlation in qualitative and quantitative manner between clinical diagnosis of retained placenta and histology. Secondly, to assess different clinical parameters that are likely related to accuracy of the diagnosis of RPOC

详细描述

Background:

Retained products of conception (RPOC) are a common and treatable complication after delivery or termination of pregnancy. The reported incidence in the literature is around 1% of all pregnancies. Most often, diagnoses are made on clinical basis and there is only scarce information available related to the correlation between the clinical and pathological diagnosis of RPOC. The gold standard for diagnosis of RPOC is based on histopathological confirmation of chorionic villi in tissue derived from the uterus. Once RPOC is diagnosed on a clinical basis, several treatment options are available, including expectant management, pharmacological treatment, and surgical interventions. Given the risks associated with surgical interventions, accurate diagnosis is vital. Guidelines at Maccabi Health Care Organization mandate that hysteroscopic removal of suspected RPOC should be performed only after approval by a Gynecological Surgical Preauthorization committee. Based on the activity of this committee and starting 2011, Maccabi has developed a database on certain gynecologic-surgical procedures including hysteroscopic removal of suspected RPOC.

Purpose of the study:

The main purpose is to evaluate the correlation in qualitative and quantitative manner between clinical diagnosis of retained placenta and histology.

Expected results:

研究设计

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

入排标准

年龄范围
18 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women who diagnosed clinically with RPOC
  • women who prefomed therapeutic hysteroscopy under the diagnosis of RPOC

排除标准

  • Women who underwent hysteroscopy presumptive diagnosis of RPOC without documentation of pathological results were excluded.
  • Women who have not performed / recorded sonography test before the hysterocpy.

结局指标

主要结局

the correlation between clinical suspicion and histological diagnosis of retained placental tissue Finding is 67.5 %.

时间窗: sep-oct 2016

次要结局

  • No clinical symptoms increase the accuracy of this diagnosis. There no advantage in the use of diagnostic hysteroscopy in case of suspected retainted placenta.(sep-oct 2016)

研究者

发起方
Bait Balev Hospital
申办方类型
Other
责任方
Sponsor

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