The Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 251
- 试验地点
- 2
- 主要终点
- Number of Participants With Non-reassuring Fetal Heart Rate Tracings During the First 30 Minutes After the Placement of Epidural Analgesia
研究概览
简要总结
Fetal heart rate patterns are an important parameter in the diagnosis of non-reassuring fetal status. Combined-spinal epidural analgesia is a method of initiating labor analgesia used by approximately 90% of the parturients at Prentice Women's Hospital. Optimizing the variables which could affect fetal heart rate patterns at the time of initiation of analgesia, such as fluid administration and oxytocin management, could help us provide better care for our patients and their fetuses.
Hypotheses: The combination of fluid administration and lower doses of oxytocin administration will have fewer adverse fetal heart rate changes in the first 60 minutes following initiation of labor analgesia.
详细描述
After obtaining informed, written consent, candidates were randomized to one of four groups at the time of request for labor analgesia. All subjects received a maintenance infusion of Lactated Ringers(LR). For candidates in Groups A or B, an intravenous bolus of 1000 mL of LR was initiated. Candidates in Groups C and D did not receive any additional fluid. If randomized to group A or C, the oxytocin management was continued as per the normal active management of labor protocal (AMOL). If randomized to groups B or D, the dose of oxytocin that was being administered was halved and not increased until 60 minutes after the initiation of epidural analgesia. Fetal heart rate monitoring and frequency of uterine contractions were recorded by external tocodynamometry.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-60
- •Healthy nulliparous or multiparous women
- •Term (>36 week gestation)
- •Singleton pregnancy
- •Spontaneous labor or with spontaneous rupture of membranes
- •Receive oxytocin
- •Request neuraxial analgesia
排除标准
- •Under 18 years of age
- •Presence of any systemic disease (e.g., diabetes mellitus, hypertension, preeclampsia)
- •Use of chronic analgesic medications
- •Prior administration of systemic opioid labor analgesia
- •Non-vertex presentation
- •Induction of labor
- •Contraindication to neuraxial analgesia.
研究组 & 干预措施
Group A
An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient is positioned for epidural placement. Oxytocin management continued as per protocol.
干预措施: Group A Intravenous bolus of 1000 ml lactated ringers solution (Drug)
Group B
An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.
干预措施: Group B Intravenous bolus bolus 1000 ml lactated ringers solution oxytocin decrease to 1/2 current rate (Drug)
Group C
The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol.
干预措施: Group C 125 mL/hr of lactated ringers (Drug)
Group D
The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. The dose of oxytocin being administered at time of epidural placement was halved and not increased for 60 minutes until after placement.
干预措施: Group D 125 mL/hr lactated ringers oxytocin decreased to 1/2 current rate (Drug)
结局指标
主要结局
Number of Participants With Non-reassuring Fetal Heart Rate Tracings During the First 30 Minutes After the Placement of Epidural Analgesia
时间窗: Request for labor analgesia up to the first 30 minutes after the placement of epidural
The number of participants who experience non-reassuring fetal heart rate tracings obtained via electronic recording during the first 30 minutes after the placement of epidural analgesia
次要结局
未报告次要终点
研究者
Paloma Toledo
Associate Professor of Anesthesiology
Northwestern University