Changes in Velocimetric Indices of Uterine and Umbilical Arteries Before and After Combined Spinal-epidural Analgesia in Laboring Women (PART I and PART II)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Umbilical artery velocimetric index - systolic/diastolic ratio (S/D) at 10 minutes
研究概览
简要总结
Combined spinal-epidural (CSE) for labor analgesia has been used for many years and is practiced commonly at our institution, especially when the patient requests immediate pain relief. CSE is not only beneficial for its faster onset of analgesia, but also it is favorable in relation to the need for rescue analgesia, urinary retention, and rate of instrumental delivery compared to the traditional epidural. Despite its beneficial effects, there is a risk of about 15-30% of developing abnormal fetal heart rate following CSE. This is self-resolving with minimal or no intervention. Although the cause of fetal bradycardia is not fully elucidated, variations in uterine artery blood flow after epidural analgesia are thought to be due to the interaction of numerous events related to blockade of sympathetic innervations, fluid administration, maternal hypotension, uterine vascular effects of sympathetic block, fluctuations in circulating catecholamines, and possibly the effect of opioids. Similar mechanism is thought to be a cause of fetal bradycardia after the CSE with its faster onset and superior block.
Maternal or fetal circulation during labor can be assessed using continuous-wave Doppler ultrasound to monitor maternal uterine artery (UtA) and fetal umbilical artery (UmA) velocity waveforms to detect changes in blood flow. The velocimetry indices mentioned above have been often used to assess the changes in the blood flow before and after the induction of epidural analgesia during labor in several studies. Although there are some studies regarding the effect of labor epidural analgesia using velocimetry indices, but there is currently no published study evaluating velocimetry indices of uterine and umbilical arteries before and after the induction of CSE. Thus, the aim of this study is to investigate the impact of CSE to maternal and fetal blood flow to evaluate the relationships.
The investigators hypothesize that both uterine artery and umbilical artery blood flow are reduced after the induction of CSE, which may be responsible for the occurrence of fetal bradycardia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •Term pregnant patients requesting labor analgesia
- •Singleton pregnancy
- •Term pregnant patients in active labor
- •No evidence of fetal congenital anomalies, fetal compromise or fetal decelerations prior to CSE
- •Patients with and without diagnosed hypertensive disorders of pregnancy
排除标准
- •Refusal to consent for the study
- •Known spinal deformities
- •Previous back instrumentation
- •Patients with BMI>50 kg/㎡ due to anticipated technical challenges in Doppler studies
结局指标
主要结局
Umbilical artery velocimetric index - systolic/diastolic ratio (S/D) at 10 minutes
时间窗: 10 minutes
Umbilical artery velocimetric index - systolic/diastolic ratio (S/D) will be measured 10 minutes after combined spinal epidural, with the uterus in relaxed and contracted states.
Umbilical artery velocimetric index - pulsatility index (PI) at 10 minutes
时间窗: 10 minutes
Umbilical artery velocimetric index - pulsatility index (PI) will be measured 10 minutes after combined spinal epidural, with the uterus in relaxed and contracted states.
Umbilical artery velocimetric index - resistance index (RI) at 10 minutes
时间窗: 10 minutes
Umbilical artery velocimetric index - resistance index (RI) will be measured 10 minutes after combined spinal epidural, with the uterus in relaxed and contracted states.
次要结局
- Umbilical artery velocimetric index - systolic/diastolic ratio (S/D) at baseline(5 minutes)
- Umbilical artery velocimetric index - pulsatility index (PI) at baseline(5 minutes)
- Umbilical artery velocimetric index - resistance index (RI) at baseline(5 minutes)
- Umbilical artery velocimetric index - systolic/diastolic ratio (S/D) at 5 minutes(5 minutes)
- Umbilical artery velocimetric index - pulsatility index (PI) at 5 minutes(5 minutes)
- Umbilical artery velocimetric index - resistance index (RI) at 5 minutes(5 minutes)
- Umbilical artery velocimetric index - systolic/diastolic ratio (S/D) at 20 minutes(20 minutes)
- Umbilical artery velocimetric index - pulsatility index (PI) at 20 minutes(20 minutes)
- Umbilical artery velocimetric index - resistance index (RI) at 20 minutes(20 minutes)
- Umbilical artery velocimetric index - systolic/diastolic ratio (S/D) at 30 minutes(5 minutes)
- Umbilical artery velocimetric index - pulsatility index (PI) at 30 minutes(30 minutes)
- Umbilical artery velocimetric index - resistance index (RI) at 30 minutes(30 minutes)
- Pain score at baseline - questionnaire(1 minute)
- Pain score at 10 minutes - questionnaire(10 minutes)
- Pain score at 30 minutes - questionnaire(30 minutes)
- Sensory block level at 10 minutes(10 minutes)
- Sensory block level at 30 minutes(30 minutes)
- frequency of uterine contractions(10 minutes)
- Presence of prolonged hypertonic uterine contractions- questionnaire(30 minutes)
- Hypotension: systolic blood pressure less than 80% of baseline(30 minutes)
- Hypertension: systolic blood pressure greater than 120% of baseline(30 minutes)
- Bradycardia: heart rate less than 70% of baseline(30 minutes)
- Desaturation: oxygen level <95%(30 minutes)
- fetal heart rate at baseline(5 minutes)
- fetal heart rate q5 min up to 30 minutes(30 minutes)
- presence of fetal bradycardia - questionnaire(30 minutes)
- presence of fetal prolonged deceleration - questionnaire(30 minutes)
- presence of fetal persistent late decelerations - questionnaire(30 minutes)
- presence of fetal non-reassuring variable deceleration - questionnaire(30 minutes)
- presence of fetal salutatory variability - questionnaire(30 minutes)
- Neonatal weight(up to 24 hours)
- Apgar score at 1 minute(1 minute)
- Apgar score at 5 minutes(5 minutes)
- Mode of delivery - questionnaire(up to 24 hours)