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临床试验/NCT02405663
NCT02405663已完成不适用

How Can Methods of Placental Delivery Affect the Amount of Blood Loss During Cesarean Section?

Benha University1 个研究点 分布在 1 个国家目标入组 288 人开始时间: 2015年4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
288
试验地点
1
主要终点
blood loss assessment after placental delivery

研究概览

简要总结

To compare between the effect of controlled cord traction and manual removal of the placenta on blood loss among women undergoing caesarean sections

详细描述

Cesarean section (CS) is one of the most commonly performed major abdominal operations in women worldwide and its rate is increasing dramatically every year.

Some of the reported short-term morbidities include hemorrhage, postoperative fever and endometritis. The method of delivering the placenta is one procedure that may contribute to an increase or decrease in the morbidity of CS.

On an average 0.5-1 liter of blood is lost during CS, many variable techniques have been tried to reduce this blood loss. Such techniques include finger splitting versus scissor cutting of incision, in situ stitching verses exteriorization and stitching of uterus , and finally spontaneous or manual removal of the placenta.

Two common methods used to deliver the placenta at CS are cord traction and manual removal.

Manual removal of the placenta which the obstetrician introduce his hand into the uterine cavity to cleave the placenta from the decidua basalis as soon as possible after the delivery of the infant and controlled cord traction in which the obstetrician do external uterine massage and gentle traction on the exposed umbilical cord to facilitate placental delivery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •All informed and consented women undergoing elective or emergency CS will be legible for enrollment into the study

排除标准

  • •Multiple gestation.
  • •Pregnancy below 34 weeks.
  • •Severe maternal anemia.
  • •Severe pre-eclampsia
  • •Prolonged labor.
  • •Prolonged rupture of the membranes with fever.
  • •Placental abruption.
  • •Placenta previa.
  • •Placenta accreta.
  • •Clotting disorders.
  • •Current or previous history of a significant disease including heart disease, liver, renal disorders.

研究组 & 干预措施

manual removal group

Experimental

Group will be assigned for manual removal of the placenta as the surgeon will introduce his hand into the uterine cavity to cleave the placenta from the decidua basalis as soon as possible after the delivery of the baby by caesarean section

干预措施: manual removal (Procedure)

cord traction group

Experimental

Group will be assigned for controlled cord traction as the surgeon do external uterine massage and gentle traction on the exposed umbilical cord to facilitate placental delivery after the delivery of the baby by caesarean section

干预措施: cord traction (Procedure)

结局指标

主要结局

blood loss assessment after placental delivery

时间窗: 12 hours

Determine estimated blood loss after placental delivery either by cord traction or manually during caesarean section through comparing pre and postoperative hemoglobin and haematocrit measurements

次要结局

  • Placental delivery time.(30 minutes)
  • Need of blood transfusion(12 hours)
  • Need to use ecbolics(30 minutes)
  • Duration of operation(2 hours)
  • Blood loss > 1000 ml(12 hours)
  • postoperative endometritis and puerperal pyrexia(one week)

研究者

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

ahmed abdulmoneim altraigey

lecturer

Benha University

研究点 (1)

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