Investigating the Novel Observation of Right-left Difference in Uterine Artery Vascular Resistance in Pre-eclampsia: A Double-blinded, Randomized, Placebo-controlled Study to Assess the Dose-dependent Effect of Epidural Lidocaine on Right-left Uterine Artery Blood Flow Differences in Pre-eclampsia, With Healthy Term Pregnant and Non-pregnant Controls
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Uterine artery pulsatility index (by Doppler ultrasound). Specifically the right-left uterine artery difference.
研究概览
简要总结
The investigators previously demonstrated that epidural ropivacaine reduces uterine artery vascular resistance in a dose dependent manner in pre-eclampsia. The investigators also noted a marked right-left difference in vascular resistance between paired uterine arteries, which was almost completely abolished following epidural ropivacaine. However, this novel observation was not a stated outcome variable before the study began. This study assesses right-left difference in vascular resistance between paired uterine arteries as a primary end-point, assesses the dose-response effect of epidural lidocaine and compares the effect observed in pre-eclampsia with that in two control populations (term normal pregnancy and non-pregnant controls).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pre-eclampsia patients and normal pregnancy controls scheduled to receive epidural catheterization for induction of labor or Cesarean delivery. Non-pregnant controls receiving epidural catheterization for elective surgery. Pre-eclampsia group:
- •gestational age between 35 to 40 completed weeks
- •uterine artery notching OR evidence of reduced uterine artery blood flow
- •resting systolic pressure > 140mmHg or diastolic pressure > 90mmHg measured twice at least 6 hours apart
- •proteinuria (at least 0•1 g/l in two random samples at least 6 hours apart or at least 0•3g in a 24 hour collection).
- •Normal pregnancy control group:
- •gestational age between 35 to 40 completed weeks
- •absence of other inclusion factors for the pre-eclampsia group. Non-pregnant control group: Non-pregnant women of reproductive age.
排除标准
- •Active labor, resting blood pressure ≥ 160/110 (recorded on at least two occasions 6 hours apart), coagulopathy or other contraindications for epidural catheterization, abnormal fetal heart tracing, known fetal anomaly, intrauterine infection, placental anomalies, twins, and refusal of consent.
研究组 & 干预措施
Epidural lidocaine
30 women to receive 5 x 5mL boluses of epidural lidocaine 2%. 10 pre-eclampsia, 10 term pregnancy, 10 non-pregnant.
干预措施: Epidural lidocaine (Drug)
Epidural lidocaine
30 women to receive 5 x 5mL boluses of epidural lidocaine 2%. 10 pre-eclampsia, 10 term pregnancy, 10 non-pregnant.
干预措施: Epidural lidocaine 2% (Drug)
Epidural saline
30 women to receive 5 x 5 mL boluses of epidural saline. 10 pre-eclamptics, 10 normal term pregnancy, 10 non-pregnant
干预措施: Epidural lidocaine (Drug)
Epidural saline
30 women to receive 5 x 5 mL boluses of epidural saline. 10 pre-eclamptics, 10 normal term pregnancy, 10 non-pregnant
干预措施: Epidural lidocaine 2% (Drug)
结局指标
主要结局
Uterine artery pulsatility index (by Doppler ultrasound). Specifically the right-left uterine artery difference.
时间窗: 15min after each dose - on a dose--response curve
次要结局
- Uterine artery pulsatility index (worse vessel)(15 min after dose)