Is Placental Transfusion Influenced by the Early Administration of Oxytocin?
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- placental transfusion
研究概览
简要总结
The purpose of this study is to determine if oxytocin administration immediately after delivery of the infant modifies the volume of placental transfusion in healthy term infants.
详细描述
Randomized controlled trial with 2 arms to test the influence of oxytocin in placental transfusion.
Placental transfusion: the amount of blood that passes to the baby from the time of birth until the cord is clamped.
The difference in weight between a measurement at birth and a second one after clamping the cord at 3 minutes will be considered as proxy for placental transfusion.
In one arm the oxytocin will be used immediately after birth and the cord clamped at 3 minutes In the other arm the oxytocin will be administered at 3 minutes of birth after the cord is clamped.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy single Term pregnancies.
- •Vaginal delivery.
- •Informed consent obtained.
- •Presence of an investigator
排除标准
- •Placenta previa.
- •Previous history of Postpartum hemorrhage
- •Intrauterine growth restriction .
- •Major congenital malformations.
- •Eclampsia
- •Extraction of blood sample for bank of umbilical cord stem cells.
- •Elimination criteria:
- •Need for immediate assistance of the newborn
- •Birth weight less than 2500 g
- •Nuchal cord wrapped too tight
- •Surgically finished delivery
- •Short umbilical cord which might prevent placing the infant on the scale
- •Technical difficulties to obtain the weight
研究组 & 干预措施
oxytocin inmediately at birth
Intervention: Timing of administration of postpartum Oxytocin. 10 international Units (IU) immediately at birth will be given intravenously (IV) to the mother.
干预措施: Timing of administration of post partum Oxytocin (Drug)
oxytocin at 3 minutes
Intervention: Timing of administration of postpartum Oxytocin. 10 IU IV at 3 minutes immediately after the cord is clamped
干预措施: Timing of administration of post partum Oxytocin (Drug)
结局指标
主要结局
placental transfusion
时间窗: between birth and 3 minutes of life
Difference in body weight between birth and 3 minutes of life
次要结局
- Maternal blood loss(after birth for 30 minutes)
- bilirubin(at 36/48 hours)
- Hematocrit(at 36/48 hours)