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临床试验/NCT02755168
NCT02755168已完成不适用

Feasibility and Outcomes of External Pop-out Versus Classic Fetal Head Extract During Cesarean Section

Assiut University2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2017年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
2
主要终点
The success rate of External POP out technique

研究概览

简要总结

Caesarean section is one the most common operations worldwide, its rates are globally increasing. A multitude of efforts had been done aiming at reduction of Caesarean section related maternal morbidities; most of them are related to technical modifications of how to open and how to close the abdominal and uterine incisions . The comparative studies of blunt versus sharp extension of the uterine incision showed a reduction of the incidence of unintended extension from 8.8% to 4.8% .

The vulnerability of the lower uterine segment for tears are related to stage of labor. The frequency of unintended extension was reported to be 15.5%, and 35.0% in cases operated in first and second stages of labor respectively.

The original techniques of fetal head extraction entail the introduction of the obstetricians hand or other instruments into the lower uterine segment . This puts the lower uterine segment at risk of damage and incision extensions with its consequences of increased blood loss, increased operative time, infection adhesions and blood transfusion. Adherence to the available the generated good quality evidence bases practice in Caesarean section is anticipated to decease such morbidities.

The idea of the present technique was derived from the fact that during vaginal delivery the main task of obstetrician is to support the perineum while the fetal head extends to get out through birth canal.

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

入选标准

  • single fetus
  • more than 37 weeks of gestation
  • elective Caesarean section

排除标准

  • non-cephalic presentation
  • placenta previa
  • hydrocephalus
  • Multiple pregnancy

结局指标

主要结局

The success rate of External POP out technique

时间窗: 20 minutes

次要结局

  • Time of head extraction(5 minutes)
  • Number of women will need blood transfusion(24 hours)
  • Easiness score:(5 minutes)

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 (2)

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