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临床试验/NCT03388827
NCT03388827Unknown2 期

The Use of Laminaria Versus Laminaria Plus Misoprostol Before Operative Hysteroscopy in Nulliparous Women . A Double Blinded Randomized Trial.

Zagazig University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年12月20日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
100
试验地点
1
主要终点
Preoperative cervical width
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Laminaria and Misoprostol before Operative Hysteroscopy

详细描述

The use of laminaria versus laminaria plus misoprostol was compared before operative hysteroscopy in nulliparous women to assess the efficacy of both methods in cervical dilatation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

double blinded

入排标准

年龄范围
18 Years 至 45 Years（Adult）
性别
Female
接受健康志愿者
是

入选标准

  • •need hystroscopic intervention

排除标准

  • •previous pregnancy
  • •cervical lesion
  • •contraindication to misoprostol

研究组 & 干预措施

Laminaria

Experimental

Laminaria tent was introduced in the cervical canal

干预措施: Laminaria tent (Device)

Laminaria plus Misoprostol

Active Comparator

Laminaria and Misoprostol were introduced

干预措施: Laminaria plus Misoprostol (Drug)

结局指标

主要结局

Preoperative cervical width

时间窗: 12 hours

cervical width in Hegar dilators number

次要结局

  • adverse effects(24 hours)

研究者

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

IBRAHIM ABD ELGAFOR

assistant professor

Zagazig University

研究点 (1)

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