The Effects of Combined Spinal-epidural Anesthetics During Labor
研究概览
详细说明
Patients will receive information regarding the available anesthesia during labor that are available in the delivery room including regional and systemic.
After receiving the patient informed consent for regional anesthesia (epidural or spinal-epidural), patients will be offered to participate in our study.
After receiving the patients' informed consent for participating in the study, patients will be randomized to either the epidural anesthesia group or to the spinal-epidural anesthesia group.
A doppler ultrasound will be performed on each patient prior to and following the regional anesthesia, the flow in the uterine artery, umbilical artery, and the middle cerebral artery of the fetus will be recorded.
Demographic and obstetrical information will be collected from the patients' electronic files.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion criteria:
Gestational age of 37 and above Singleton Vertex presentation Desired regional anesthesia
Exclusion criteria:
Contraindication to regional anesthesia Placental abnormalities (placenta previa, placenta accreta, placental separation) Pregnancy following fetal reduction or intrauterine fetal death (IUFD) Fetal malformations Intrauterine growth retardation (IUGR) Suspected chorioamnionitis (including body temperature above 38.5 degrees Celsius)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Epidural Anesthesia
Women in labor receiving epidural anesthesia
|
Performing an epidural anesthesia
|
|
有源比较器：Spinal-epidural
Women in labor receiving spinal-epidural anesthesia
|
Performing a spina-epidural anesthesia
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Uterine artery flow
大体时间：Up to 48 hours from onset of anesthesia
|
Changes in uterine artery flow before and after regional anesthesia
|
Up to 48 hours from onset of anesthesia
|
|
Umbilical artery flow
大体时间：Up to 48 hours from onset of anesthesia
|
Changes in umbilical artery flow before and after regional anesthesia
|
Up to 48 hours from onset of anesthesia
|
|
Middle cerebral artery flow
大体时间：Up to 48 hours from onset of anesthesia
|
Changes in middle cerebral artery flow before and after regional anesthesia
|
Up to 48 hours from onset of anesthesia
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Fetal heart rate abnormalities
大体时间：Up to 48 hours from onset of anesthesia
|
Fetal heart rate deceleration
|
Up to 48 hours from onset of anesthesia
|
|
Fetal bradycardia within 1 hour
大体时间：Up to one hour from onset of anesthesia
|
Fetal bradycardia
|
Up to one hour from onset of anesthesia
|
|
Mode of delivery
大体时间：Up to delivery
|
Mode of delivery - vaginal/instrumental/cesarean section
|
Up to delivery
|
|
Meconial amniotic fluid
大体时间：Up to delivery
|
Meconial amniotic fluid
|
Up to delivery
|
|
Umbilical artery blood acidity level (PH)
大体时间：Immediate after delivery
|
Umbilical artery blood PH
|
Immediate after delivery
|
|
Apgar at 1 and 5 minutes
大体时间：Up to 5 minutes from delivery
|
Apgar at 1 and 5 minutes
|
Up to 5 minutes from delivery
|
|
Admission to Neonatal Intensive Care Unit (NICU)
大体时间：Up to 72 hours from delivery
|
Admission to NICU
|
Up to 72 hours from delivery
|
合作者和调查者
调查人员
- 首席研究员：Saar Aharoni, MD、Rambam Heath-Care Campus
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.