A Clinical Trial Evaluating the Interaction of Rapid Hydration and the Rate of Oxytocin Labor Augmentation on Fetal Heart Rate Changes and Maternal Fetal Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Incidence of Non-reassuring Fetal Heart Rate Tracings.
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: Patients who receive a 1000 mL fluid bolus and lower rates of oxytocin administration will have fewer non-reassuring fetal heart rate (FHR) changes.
详细描述
Informed, written consent will be obtained. At the time of request for labor analgesia, group assignment will be determined by opening an opaque envelope. Patients will be randomized to one of four groups.
All subjects will receive a maintenance infusion of 125 mL Lactated Ringers (LR) solution throughout the study. For patients in Groups A or B, an intravenous bolus of 1000 mL LR will be initiated when the patient is positioned for epidural placement. The bolus will be administered through a free-flowing wide open intravenous catheter until complete.
Patients in Groups C and D will not receive any additional fluid bolus and will only receive the maintenance infusion of 125 mL LR during the study period. Blinding will be maintained by the Labor and Delivery nurse by covering up the LR bolus fluid bag.
If the patient is randomized to groups B or D, the dose of oxytocin currently being administered will be halved and not increased for the duration of the study period (60 minutes after the initiation of CSE).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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 and over
- •Healthy nulliparous or multiparous women
- •Term (>36 week gestation)
- •Singleton pregnancy
- •Spontaneous labor or spontaneous rupture of membranes
- •Receive oxytocin
- •Request neuraxial analgesia
排除标准
- •Under 18 years old
- •Presence of any systemic disease (ex: diabetes mellitus, hypertension, preeclampsia
- •Use of chronic analgesic medications
- •Prior administration of system opioid labor analgesia
- •Non-vertex presentation
- •Induction of Labor
- •Contraindication to neuraxial analgesia
研究组 & 干预措施
Routine Oxytocin
Lactated Ringers bolus of 1000 mL will be initiated when the patient is positioned for epidural placement. Oxytocin management will continue as per the routine oxytocin protocol
干预措施: Routine oxytocin (Drug)
Half-dose Oxytocin
Lactated Ringers bolus of 1000 mL will be initiated when the patient is positioned for epidural placement. A half-dose oxytocin will be initiated and not increased until 60 minutes after.
干预措施: Half-dose oxytocin (Drug)
结局指标
主要结局
Incidence of Non-reassuring Fetal Heart Rate Tracings.
时间窗: Request for labor analgesia up to the first 60 minutes after the epidural placement
Incidence of non-reassuring fetal heart rate tracings during the first 60 minutes after the placement of epidural analgesia
次要结局
未报告次要终点