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临床试验/NCT03148561
NCT03148561已完成不适用

Misoprostol Versus Expectant Management in Women With Incomplete First-trimester Miscarriage After Misoprostol Treatment: A Randomized Clinical Trial

Assiut University1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2017年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
1
主要终点
The number of patients with complete miscarriage at 1 week.

研究概览

简要总结

Miscarriage is defined as the spontaneous loss of a pregnancy before 24 weeks' gestation, that is, before the fetal viability. The clinical signs of miscarriage are usually vaginal bleeding associated abdominal pain and cramping . The miscarriage is named 'complete' or 'incomplete' according to whether or not tissues are retained in the uterus. If a woman has minimal bleeding but her cervix is closed, this is known as a 'threatened miscarriage. However; if the pregnancy is still inside the uterus but the cervix is open, this is described as an 'inevitable miscarriage', which it will not usually be possible to save the fetus.

From many years, the surgical curettage ('evacuation of the uterus') was considered the 'gold standard management' for miscarriage to remove the retained placental tissue. It is quickly performed and removed almost all the retained products of conception. However, the routine surgical evacuation of the uterus associated with higher rate of morbidity and mortality and should be limited for special indications.

Many studies compared the effectiveness of medical treatment compared to surgery in management of incomplete abortion. There is only one study compared the curettage with expectant management in those women after medical therapy.However; none of them, looked at the effectiveness of the second chance of medical treatment in management of incomplete abortion in trial to avoid the surgical intervention after failure of previous medical treatment. So we think that the immediate evacuation using surgical intervention is truly unnecessary in most cases of failed medical abortion and the patients may get benefit from another trial of medical treatment.

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
None

入排标准

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

入选标准

  • Women with confirmed incomplete induced miscarriage, less than 12 weeks' gestation.
  • No known allergy to misoprostol.
  • Women who will be haemodynamically stable.
  • Good access to emergency facilities. Exclusion
  • Women with signs of severe infection ( fever > 38°)
  • Women with severe vaginal bleeding
  • Women known to have allergy to prostaglandins
  • Severe abdominal pain requiring immediate intervention

排除标准

  • 未提供

研究组 & 干预措施

Misoprostol group

Other

The women received misoprostol 800 µg (Misotac 200 µg tablets, SIGMA pharmaceutical, Egypt) once dose placed in the posterior vaginal fornix

干预措施: Misoprostol (Drug)

结局指标

主要结局

The number of patients with complete miscarriage at 1 week.

时间窗: 1 week

次要结局

未报告次要终点

研究者

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

Mohammed Khairy Ali

Lecturer

Assiut University

研究点 (1)

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