The Effect of Warmed Parenteral Fluids During Vaginal Delivery and Cesarean Section
试验速览
- 阶段
- 不适用
- 入组人数
- 7,000
- 试验地点
- 1
- 主要终点
- Length of the second stage of labor
研究概览
简要总结
To evaluate the influence of warm IV fluids during delivery and cesarean section on perinatal outcomes.
详细描述
Prospective randomized controlled trial. Assessing the influence of warmed parenteral fluids during delivery/cesarean section on the obstetrical and neonatal outcome. The investigators will randomize parturients during the active phase of labor to receive either body temperature warmed parenteral fluids or room temperature parenteral fluids. Both groups will receive the same fluid composition of 5% dextrose with normal saline. The investigators will compare the obstetrical and neonatal outcomes of the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancies
- •term pregnancies
- •receiving parenteral fluids
排除标准
- •high order pregnancies
- •preterm pregnancies (before 37 weeks of gestation)
- •known fetal major anomaly
- •known fetal significant chromosomal/genetic abnormality
研究组 & 干预措施
Room temperature parenteral fluids
This group will receive IV room temperature fluids, which is the standard of care.
The composition of the fluids given will be normal saline with 5% dextrose.
Body temperature parenteral fluids
This group will receive IV warmed fluids, body temperature, which is the experimental intervention.
The composition of the fluids given will be normal saline with 5% dextrose.
干预措施: Body temperature parenteral fluids (Other)
结局指标
主要结局
Length of the second stage of labor
时间窗: up to 5 hours from complete cervical dilation
How much time did it take from complete cervical dilation to the delivery of the baby.
次要结局
- Prevalence of perineal tears and episiotomies(immediately after vaginal birth)
- Neonatal APGAR score(up to 5 minutes from delivery)
- The rate of prolonged second stage(immediately after completion of the delivery.)