Pulse Pressure-guided IV Fluid Preload to Prevent Post-epidural Fetal Heart Rate (FHR) Changes: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Incidence of New-onset Category II or III Fetal Heart Rate Tracings
研究概览
简要总结
Epidural anesthesia, the most common method of pain control in labor, can contribute to alterations in maternal blood pressure and/or fetal heart rate changes. As a result, the administration of an IV fluid bolus ("preload") is standard prior to epidural placement. However, the optimal volume of preload is unknown and no clinical trials have evaluated a risk-factor based approach to dosing. Studies in the critical care, trauma, and obstetric literature have suggested that a narrow pulse pressure (difference between systolic and diastolic blood pressures) is a marker of reduced intravascular volume status and may identify women at a higher risk for new onset fetal heart rate changes after epidural placement. Therefore, the purpose of this study is to assess if an increased IV fluid preload bolus among women with a narrow pulse pressure reduces the risk of new onset fetal heart rate changes after epidural placement.
详细描述
Objective:
To assess the efficacy of increased IV fluid preload for the prevention of post-epidural FHR changes in women with narrow pulse pressure
Hypothesis:
In individual with narrow pulse pressure, an increased IV fluid bolus will reduce the rate of post-epidural FHR changes.
Background:
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnancy with gestational age ≥ 35 weeks
- •Admission for delivery
- •Age 18 or older
- •Desires neuraxial analgesia in labor
- •No exclusion criteria
- •Maternal pulse pressure < 45 mmHg on admission (verified by repeat blood pressure)
- •Category 1 FHT on admission/prior to epidural placement
- •Epidural placement within 6 hours of admission to Labor and Delivery
排除标准
- •Multiple gestation
- •Intrauterine growth restriction
- •Hypertensive disorders (gestational hypertension, chronic hypertension, and preeclampsia/eclampsia)
- •Gestational or pregestational diabetes mellitus
- •Substance abuse
- •Intrauterine fetal demise
- •Congenital or chromosomal fetal abnormalities
- •Category II or III FHR tracing on admission to L&D (pre-epidural)
- •Contraindication to neuraxial aesthesia (e.g. thrombocytopenia)
- •Maternal cardiomyopathy, congenital heart disease, active pulmonary edema or any other underlying maternal cardiopulmonary condition that increases the risk of pulmonary edema
- •Maternal renal insufficiency (serum creatinine > 1.0)
- •Maternal hypotension (as defined in secondary outcomes below) prior to epidural placement
研究组 & 干预措施
Volume Replacement IV Preload
Patients in this arm will receive 1500mL of Lactated Ringer's solution
干预措施: Lactated Ringer's (Drug)
结局指标
主要结局
Incidence of New-onset Category II or III Fetal Heart Rate Tracings
时间窗: First 60 minutes following epidural placement
Each fetal heart rate tracing was evaluated in 15 min increments from the completion of epidural placement and initial dose administration. ACOG Category I, II, and III was assigned to each 15 min increment.
次要结局
- New Onset Hypotension (>20% Decrease in Systolic and/or Diastolic Blood Pressure)(First 60 minutes following epidural placement)
- Adverse Events (Pulmonary Edema)(Duration of intrapartum course)
- Interventions to Correct Maternal Hypotension or Fetal Heart Rate Abnormalities (Position Change, Supplemental Oxygen, Vasopressor Support, Emergent Operative Delivery)(First 60 minutes following epidural placement)
研究者
Edward Chien, MD
Professor, Reproductive Biology
MetroHealth Medical Center