Comparison of Haemodynamic and Cardiovascular Effects of Carbetocin and Oxytocin in Women Undergoing Elective Caesarean Section: A Double-blinded Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Haemodynamic effects
研究概览
简要总结
A double-blinded randomised control trial conducted in the Department of Obstetrics and Gynaecology of a tertiary hospital, Universiti Kebangsaan Malaysia Medical Centre (UKMMC) for two years duration from January 1st, 2012 till December 31st, 2013.
The aim of the study is to compare the haemodynamic and cardiovascular effects between intravenous carbetocin 100 μg and intravenous oxytocin 5 IU in women undergoing elective Lower Segment Caesarean Section (EL LSCS).
Study hypothesis: A single injection of carbetocin is haemodynamically and cardiovascularly safe and has similar efficacy in comparison to a single injection of oxytocin.
详细描述
OUTCOME MEASURES systolic blood pressure (SBP), diastolic blood pressure (DBP), Heart Rate (HR), saturation of oxygen (SpO2) in certain time after drug injection.
The presence of myocardial ischemia symptoms and side effects of both drugs, ECG changes such as ST depression and changes in T-waves.
Hemoglobin and troponin-T level
The need for additional oxytocin infusion and estimated blood loss
The time interval between initial drug administration, type of additional oxytocic intervention that used and complication that happened.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Viable, singleton pregnancy ≥ 37 weeks gestation undergoing EL LSCS.
- •Low risk for post-partum hemorrhage, such as no proven abruptio placentae, placenta previa, multiple pregnancy, pre-eclampsia / gestational hypertension, previous PPH, obesity (based on BMI pre pregnancy which is ≥ 30 kg/m2), big baby.
- •Ability to provide informed consent.
排除标准
- •Emergency caesarean section
- •Preterm Labour
- •Grandmultipara
- •Multiple Pregnancy
- •Placenta Previa
- •Previous PPH
- •Maternal Obesity ( BMI pre pregnancy ≥ 30 kg/m2))
- •Have co-morbidity illness such as hypertension/pre-eclampsia, established cardiac diseases, history or evidence of liver, renal, vascular, or endocrine disease and bleeding disorder.
- •Contraindication to carbetocin and oxytocin
- •Language Barrier
- •Women undergoing general anaesthesia
- •Women who has abnormal baseline ECG that suggestive myocardial ischemia
研究组 & 干预措施
Carbetocin
Carbetocin 100 µg, given as an intravenous bolus over 30 seconds others names are: duratocin, pabal
干预措施: Carbetocin (Drug)
Oxytocin
Other names are Pitocin, syntocinon given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group.
干预措施: Oxytocin (Drug)
结局指标
主要结局
Haemodynamic effects
时间窗: 2 years
1. Haemodynamic effect (blood pressure, heart rate, saturation of oxygen) 2. Presence of ECG changes such as ST depression and changes in T-waves 3. Presence of myocardial ischemia symptoms (such as chest pain, shortness of breath, feeling of heaviness in chest pain) 4. To compare the troponin T levels
次要结局
- Blood loss measurement(2 years)
研究者
Nirmala Chandralega Kampan
MRCOG(UK)
Universiti Kebangsaan Malaysia Medical Centre