The Pharmacokinetics of Oxytocin in Pregnant Women Undergoing Cesarean Delivery - a Feasibility Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Venous [OXT]
研究概览
简要总结
The primary objective is to obtain data to inform the design of a population pharmacokinetic study of oxytocin after administration at CD as per standard institutional practice.
详细描述
In this pilot study the investigators will compare plasma oxytocin concentrations measured in arterial and venous blood, after oxytocin administration at cesarean delivery, in order to assess the validity of venous samples. They will also measure oxytocinase to explore how levels vary around the time of delivery of the placenta and to assess the effect that this may have on the metabolism of oxytocin.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Term singleton pregnancy
- •Age 18-45 years of age
- •ASA classification 2 or 3
- •Scheduled cesarean delivery under neuraxial anaesthesia
排除标准
- •Age or ASA classification outside of inclusion criteria
- •Need for general anaesthesia
- •Absence of consent
- •Inability to communicate in English or other barrier to providing informed consent
研究组 & 干预措施
BMI 20 - 29.9 kg/m2
干预措施: oxytocin (Drug)
BMI 20 - 29.9 kg/m2
干预措施: Shore durometer (Device)
BMI > 30 kg/m2
干预措施: oxytocin (Drug)
BMI > 30 kg/m2
干预措施: Shore durometer (Device)
结局指标
主要结局
Venous [OXT]
时间窗: Scheduled samples during the first 30 minutes after oxytocin administration
Concentration of oxytocin in venous samples
Arterial [OXT]
时间窗: Scheduled samples during the first 30 minutes after oxytocin administration
Concentration of oxytocin in arterial samples
次要结局
- Arterial [OXTase](Scheduled samples during the first 30 minutes after oxytocin administration)
- Hypotension(Measured intraoperatively)
- Uterine tone(Scheduled measurements during the first 30 minutes after oxytocin administration)
- EBL(Estimated at the end of surgery)
- Nausea & Vomiting(Recorded intraoperatively)