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临床试验/NCT00222066
NCT00222066已完成不适用

Comparison Between Abstention and Intrauterine Aspiration in the Treatment of Anechoic Fetal Ovarian Cysts to Prevent Ovarian Torsion

University Hospital, Tours5 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2001年6月最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
入组人数
61
试验地点
5
主要终点
To avoid neonatal surgery
研究概览研究设计入排标准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

The purpose of this study is to determine whether prenatal ovarian cyst aspiration is effective and safe to prevent perinatal ovarian torsion.

详细描述

With the widespread use of routine sonography during pregnancy, the incidence of fetal ovarian cysts detected in utero has increased in the past decades. However

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •Pregnant women having an uneventful single pregnancy and a female fetus diagnosed with anechoic ovarian cyst (diameter at least 30mm)

排除标准

  • •Multiple pregnancy
  • •Complicated pregnancy (PE, diabetes, PROM, fetal malformation)
  • •Echoic cyst (fluid debris level, septated, retracting clot, globally echoic)
  • •Unability to give informed consent

结局指标

主要结局

To avoid neonatal surgery

时间窗: 3 months after birth

次要结局

  • Ultrasound pattern of neonatal ovarian cyst(3 months after birth)
  • Maternal and fetal/neonatal safety of prenatal ovarian cyst aspiration(3 months after birth)

研究者

申办方类型
Other

研究点 (5)

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