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临床试验/NCT04326595
NCT04326595Unknown不适用

Histopathological Evaluation of Product of Conception in Sporadic and Recurrent Abortions

Assiut University0 个研究点目标入组 300 人开始时间: 2020年12月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
300
主要终点
percentage of results of products of conception assessed by histopathological evaluation

研究概览

简要总结

  1. To evaluate histopathological findings of products of conception in both sporadic and recurrent miscarriage.
  2. To determine the prevalence of chronic histiocytic intervillositis in both sporadic and recurrent miscarriage.

详细描述

Early miscarriage is a term used to describe the loss of pregnancy within the first 12 weeks of gestation .This diagnosis concerns 10-15% of all pregnancies and is made based on additional tests such as serial determinations of chorionic gonadotropin concentration and imaging examinations ultrasonography. Depending on the clinical presentation and results of ultrasonography, miscarriages can be divided into complete spontaneous miscarriage, and incomplete miscarriage, when the width of the echo of residual tissues in the uterine cavity exceeds 10 mm on ultrasonography and is accompanied by the presence of clinical symptoms such as vaginal bleeding and abdominal pain .The other type of miscarriage is defined as retained products of conception (RPOC) and refers to the state when the gestational sac contains the embryo with crown-rump length (CRL) of > 7 mm but embryonic cardiac activity is invisible. Empty gestational sac is diagnosed when the gestational sac with a diameter of > 25 mm and without an embryo is visible in the uterine cavity on ultrasonography .

Histopathological examination of products of conception is an integral and a routine component of the management of patients with early pregnancy failure . Two important primary reasons for such an examination are to confirm the presence of an intrauterine gestation and to exclude gestational trophoblastic disease in the form of partial or complete hydatidiform mole .

研究设计

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

入排标准

年龄范围
17 Years 至 40 Years(Child, Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •all pregnants with clinical symptoms and signs of abortion
  • •fit for medical induction of abortion
  • •fit for surgical procedure

排除标准

  • •threatened abortion
  • •complete abortion
  • •unfit participants for medical abortion
  • •unfit participants for surgical procedure

研究组 & 干预措施

surgical termination

Active Comparator

干预措施: surgical and medical evacuation (Procedure)

medical termination

Active Comparator

干预措施: surgical and medical evacuation (Procedure)

结局指标

主要结局

percentage of results of products of conception assessed by histopathological evaluation

时间窗: one year

to asses the result of analysis of products of abortion and divide them into groups according to the results and asses percentage of each type types predicted :1-products of conception 2-no products of conception 3-partial moel 4-complete mole 5-Arias-stella reaction 6-others

次要结局

  • rate of participants show chronic histiocytic intervillositis in histopathological evaluation(one year)

研究者

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

MOHAMMED HAGGAG HASHIM

Principal Investigator

Assiut University

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