Oxytocin Administration During Cesarean Section Before Versus After Fetal Delivery Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- rate of blood loss
研究概览
简要总结
Cesarean delivery is defined as fetal birth through incisions in the abdominal wall and the uterine wall. This definition does not include removal of the fetus from the abdominal cavity in the case of uterine rupture or in the case of an abdominal pregnancy The guidelines of the Royal College of Obstetricians and Gynaecologists on caesarean section recommend a slow intravenous bolus dose of 5 IU of oxytocin after delivery of the infant. Intravenous oxytocin has a short half life (4-10 minutes); therefore the potential advantage of an oxytocin infusion at caesarean section is in maintaining uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhage occurs
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
- 否
入选标准
- •Primigravida or multigravida
- •Term (37 - 42 weeks),
- •Singleton pregnancies
- •Booked for elective caesarean section.
- •Accepting to participate in the study.
排除标准
- •• Medical disorders involving the heart, liver, kidney or brain.
- •Diabetes mellitus and hypertension.
- •Blood disorders (e.g. coagulopathies, thrombocytopenia)
- •Patients requiring blood transfusion due to anemia.
- •Risk factors for uterine atony e.g. macrosomia, polyhydramnios and multiple pregnancy.
- •Previous 2 or more cesarean section
- •Placenta previa or placental abruption
- •Previous major obstetric haemorrhage (>1000 ml) in previous deliveries.
- •Known fibroid or adenomyosis.
- •Women who received anticoagulant therapy.
- •Severe preeclampsis.
- •Uterine anomalies.
研究组 & 干预措施
study group
100 women were assigned to receive an intravenous infusion of oxytocin 30 units in a rate 125 mL/hour minutes diluted into 500 mL of normal 0.9% sodium chloride) immediately after opening the visceral peritoneum just before incising the uterine wall during Cesarean section
干预措施: Oxytocin (Drug)
Control group
100 women were assigned to an intravenous infusion of oxytocin 30 units in a rate 125 mL/hour diluted into 500 mL of normal 0.9% sodium chloride) immediately after clamping the umbilical cord during cesarean section
干预措施: Oxytocin (Drug)
结局指标
主要结局
rate of blood loss
时间窗: 4 hours
collection of the blood in the drape below the patient
次要结局
未报告次要终点
研究者
Ahmed Mohamed Abbas
principal investigator
Assiut University