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临床试验/NCT02580175
NCT02580175已完成不适用

Surgical Evacuation of First Trimester Missed Miscarriage With or Without Use of Transabdominal Ultrasound

Assiut University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2014年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Measurement of endometrial thickness by ultrasound (mm)

研究概览

简要总结

Abortion is considered the most common cause of fetal demise all over the world. The majority of cases occur in the first trimester. The termination of abortion may be by medical or surgical methods, however; the surgical methods represent the greater part of termination. Therefore, the safety of this procedure is a worldwide public health concern. Many clinical studies have reported the safety of surgical evacuation in the first trimester.

The suction-aspiration or vacuum aspiration is the most common surgical method of induced abortion. This consists of removing the fetus, embryo, placenta, and membranes by suction using a manual syringe or electric pump. However; these techniques always need cervical dilation before aspiration. The menstrual extraction does not require cervical dilation and can be used in very early pregnancy.

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
Single (Participant)

入排标准

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

入选标准

  • •women with non-viable first trimester intrauterine pregnancy
  • •no contraindication to surgical evacuation under general anesthesia

排除标准

  • •gestational age more than 13 weeks
  • •hemodynamically unstable
  • •suspicion of an ectopic pregnancy

研究组 & 干预措施

Blinded evacuation

Active Comparator

Ring evacuation was performed in the conventional way without use of ultrasound followed by sharp gentle curettage until complete evacuation

干预措施: Blinded evacuation (Procedure)

Evacuation under ultrasound guidance

Active Comparator

Ring evacuation was performed under ultrasound guidance followed by sharp gentle curettage until complete evacuation. The surgery was considered complete when the endometrial cavity appeared as a regular echogenic line.

干预措施: Evacuation under ultrasound guidance (Procedure)

结局指标

主要结局

Measurement of endometrial thickness by ultrasound (mm)

时间窗: 1 month

次要结局

  • Measurement of blood loss (mL)(1 month)
  • measurement of operative time (minutes)(1 month)
  • measurement of Hemoglobin level(g/ml)(1 month)

研究者

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

Mohammed Khairy Ali

Dr

Assiut University

研究点 (1)

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