External Pop Out Caesarean Section Versus Conventional Method for Fetal Head Extraction in Repeated Caesarean Section, a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Rate of uterine incision extension or LUS injury
研究概览
简要总结
To establish feasibility and safety of the use of external pop out as a novel technique for foetal head delivery during c s, the effect of application of this method on a previously scarred uterus will be studied as a better way regarding preservation of the integrity of the lower uterine segment, operative time, time needed for head delivery, incision extension, blood loss, incidence of bladder injury.
详细描述
Caesarean delivery (cs) is the most common major surgical procedure performed with over 1,2million performed per year . The increase in caesarean section rates seems uncontrollable with no signs that it is slowing down .
A great concern of caesarean delivery complications is incision extension , un intended extensions of uterine incision frequently occurs at the time of caesarean delivery with estimated incidence of 4-8% .
Some measures are taken to guard against incision extension as expansion of uterine incision in cephalocaudal direction which is associated with lower risk of un intended extension Head extraction during caesarean section is one of the most critical steps during caesarean section and one of the major contributors to un intended uterine incision extension . Delivery of the foetal head should be within 3minutes from opening the uterine incision.
Difficult extraction causes different hazards as foetal respiratory distress syndrome , incision extension, bleeding.
The original technique of foetal head extraction entails introduction of obstetrician hands or other instruments into lower uterine segment (LUS) .
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Cases with repeated c s.
- •Elective c s.
- •Singleton pregnancy.
- •Full term pregnancy.
- •BMI below30
- •Cephalic presentation.
- •Women who accepted to participate in the study.
- •Placenta away from the lower segment
排除标准
- •Fibroid uterus.
- •Infection as chorioamnionitis.
- •Maternal comorbidities.
- •Uterine anomalies.
- •Major Foetal congenital anomalies.
- •Placenta previa.
- •Placental separation.
- •Dehiscent LUS scar as assessed by us with cut off value 2.5mm.
研究组 & 干预措施
• Group 1(conventional c s)
this arm will be exposed to the conventional method of cesserian section which entail introduction of the operator hand below the fetal head during its extraction
• Group2(EPO technique)
this group will be exposed to external pop out teqnique which entails support of lower uterine segment without introduction of the obstetrician hand into uterine incision
结局指标
主要结局
Rate of uterine incision extension or LUS injury
时间窗: through the study completion average one year
The percentage of participants who developed uterine incision extension or lower uterine segment injury in both groups of study.
次要结局
- The degree of severity of incision extension or injury(through the study completion average one year)
- Amount of intraoperative blood loss(through the study completion average one year)
- Total operative time and uterotomy to head delivery time(through the study completion average one year)
- Post operative hemoglobin level(24 hours postoperative in each participant through the study completion average one year)
- Need for blood transfusion(Intraoperative or postoperative before discharge from the hospital)
- Hospital stay(Through the study completion average one year)
研究者
Azhar Samir Aboelfadl
director
Assiut University