The Effect of Placental Spontaneous Delivery Versus Manual Removal on Blood Loss During Cesarean Section. A Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Blood loss
研究概览
简要总结
The mode of placental delivery may contribute to an increase or decrease in the morbidity associated with CS, and many studies have shown it to be a key role in determining the blood loss during CS. Manual removal of the placenta has been implicated in increased blood loss during CS. However, other researchers concluded that it had no detrimental effect on blood loss
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age (18 - 35) years.
- •Primigravida.
- •Unscarred uterus.
- •Singleton pregnancy.
- •Living baby.
- •Body mass index (18 - 30) 37-40 weeks
排除标准
- •Emergency cesarean section due to possibility of maternal distress and blood loss.
- •Cesarean hysterectomy as the placenta will be removed with the uterus.
- •Abnormally adherent placenta: Placenta accrete, percreta or placenta previa due to failure of placental separation.
- •Previous cesarean section as the previous scar may affect placental separation.
- •Body mass index less than 18 and more than 30 as extremes of body weight may be associated with increased risks of anemia, bleeding and/or infection.
- •Suspected chorioamnionitis to decrease the risk of disseminated infection.
- •Bleeding disorders to decrease blood loss.
- •Multiple pregnancy due to larger placental volume and blood loss compared with singleton.
- •Any pelvic surgery (Appendix - Ovarian cyst. - Ectopic Pregnancy - pelvic abscess)
- •Women with medical illness e.g. pre-eclampsia, anemia (Hb less than 11 gm/dl), DM, Cardiac, Renal ...etc. to decrease the risk of maternal morbidity.
研究组 & 干预措施
Spontaneous separation
Manual separation
干预措施: Manual placental separation (Procedure)
结局指标
主要结局
Blood loss
时间窗: 24 hours
The blood loss during cesarean section and in the first 24 hours postoperatively will be assessed in a standard manner. Blood will be measured after suction of the mount of amniotic fluid in a separate suction bottle. Amount of blood which collected from towels will be measured according to gravimetric method which reported by Liu et al. (2020). - EBV x (Hi-Hf)/Hi: Where the Hi is the preoperative blood hematocrit, Hf is the postoperative one and EBV is the estimated blood volume. The estimated blood volume could be calculated by multiplying weight times average blood volume which is around 65 ml/kg in females (Miller et al., 2000).
次要结局
未报告次要终点