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临床试验/NCT03009994
NCT03009994已完成不适用

Exteriorization Versus Non-exteriorization of the Uterus During Repair of Uterine Incision in a Repeated Cesarean Section

Assiut University2 个研究点 分布在 1 个国家目标入组 1,024 人开始时间: 2016年9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
1,024
试验地点
2
主要终点
Postoperative Hemoglobin (gm/L)

研究概览

简要总结

Cesarean section is one of the most frequently performed major operations worldwide. It accounts for between 1% and 70% of deliveries depending on the facilities or country assessed. In Egypt, the cesarean section rate is 22%, with higher rates seen in private hospitals. In 2015 ,incidence of cesarean section rate in Woman Health Hospital in Assiut university is 51.3% of all deliveries.

Different Operational techniques For cesarean section have been defined aimed at reducing surgical time, making the surgery easier and more efficient, lowering costs,decreasing the risk of adverse effects and postoperative morbidity, as well as length of hospital stay.

Also, Intraoperative blood loss is one of important complications during cesarean section. A systematic review included twenty one studies, in 2011, revealed that increase incidence of intraoperative blood loss and blood transfusion with increase number of cesarean deliveries.also anemia in the pregnancy increase maternal morbidities included intraoperative blood loss. In Egypt, prevalence of Iron deficiency anemia among pregnant women about 51% of pregnant women.

After baby born by cesarean section and the placenta has been extracted, uterine incision is sutured either by temporary removal of the uterus from the abdominal cavity (exteriorization of the uterus) to facilitate uterine incision repair or it is repaired within the abdominal cavity (in situ repair). There had been few randomized controlled trials comparing intraoperative and postoperative morbidity following exteriorization of the uterus with non-exteriorization. The conclusions drawn from these trials have been conflicting.

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

  • Pregnant women in 28 weeks
  • Women who will undergo repeated lower segment cesarean section

排除标准

  • First cesarean section
  • Placenta previa.
  • Rupture uterus.
  • Classical caesarean section.(upper segment cesarean section)
  • Sever Preeclampsia.
  • Chorioamnionitis.
  • prolonged or obstructed labour.
  • Polyhydramnios.
  • Multiple pregnancy.

结局指标

主要结局

Postoperative Hemoglobin (gm/L)

时间窗: 20 minutes

Intraoperative blood loss (mL)

时间窗: 20 minutes

次要结局

  • Duration of operation (minutes)(20 minutes)

研究者

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

Mohammed Khairy Ali

Prof

Assiut University

研究点 (2)

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