Oxytocin Maintenance Infusion in Labouring Women Undergoing Cesarean Delivery: an Up-down Sequential Allocation Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Uterine tone up to discharge from the post anesthetic care unit (PACU): questionnaire
研究概览
简要总结
This study is designed to determine the minimal effective oxytocin maintenance infusion required in labouring women undergoing cesarean delivery to achieve the best effect. Oxytocin is a drug that is routinely used to help the uterus to contract and keep it contracted after delivery. Consequently, it will help to reduce blood loss after delivery. In order to determine the minimal effective dose, the investigators will conduct a dose-finding study. The first patient will receive a set oxytocin infusion. The next patient's infusion dose of oxytocin, will either increase or decrease, depending on how the previous patient responds in terms of uterine tone. If the response is satisfactory with the infusion dose used, the next patient will either receive the same infusion dose or it will be decreased depending on a probability of 1:9. If the response is not satisfactory, then the infusion dose will increase for the next patient. The dose for each patient will be determined based on the results of the uterine contraction of the previous patient.
The investigators hypothesize that the ED90 of the oxytocin infusion rate to maintain adequate uterine tone in labouring women with induced or augmented labour undergoing cesarean delivery, following an initial effective bolus dose, would be lower than 0.74 IU/min (44 IU/h), which was found as the ED90 in a previous study, without an initial bolus dose prior to the infusion.
详细描述
This study will be conducted as a prospective, double blinded clinical trial (patient, anesthesiologist and obstetrician blinded to the oxytocin dose), in an up-down sequential allocation fashion. The objective of the study is to determine the minimum effective dose of oxytocin infusion required to produce appropriate uterine contraction during and after cesarean delivery under neuraxial anesthesia in laboring women. For the purpose of this study, the minimum effective dose is defined to be that at which adequate response occurs in 90% of patients, i.e. ED90.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 是
入选标准
- •All patients with induced or augmented labour undergoing cesarean delivery under neuraxial anesthesia (at least 3 hours of prior exposure to oxytocin during labour)
排除标准
- •All patients who refuse to give written informed consent
- •All patients who declare allergy or hypersensitivity to oxytocin
- •A history of hypertension and/or severe cardiac disease(s)
- •All patients who have contraindications for neuraxial anesthesia
- •All patients who will be converted to general anesthesia intraoperatively
- •All patients with placenta previa and multiple gestation
研究组 & 干预措施
Oxytocin infusion rate 4 IU/h
The maintenance infusion rate of oxytocin will be 4 IU/h.
干预措施: Oxytocin (Drug)
Oxytocin infusion rate 6 IU/h
The maintenance infusion rate of oxytocin will be 6 IU/h.
干预措施: Oxytocin (Drug)
Oxytocin infusion rate 10 IU/h
The maintenance infusion rate of oxytocin will be 10 IU/h.
干预措施: Oxytocin (Drug)
Oxytocin infusion rate 14 IU/h
The maintenance infusion rate of oxytocin will be 14 IU/h.
干预措施: Oxytocin (Drug)
Oxytocin infusion rate 18 IU/h
The maintenance infusion rate of oxytocin will be 18 IU/h.
干预措施: Oxytocin (Drug)
Oxytocin infusion rate 26 IU/h
The maintenance infusion rate of oxytocin will be 26 IU/h.
干预措施: Oxytocin (Drug)
Oxytocin infusion rate 22 IU/h
The maintenance infusion rate of oxytocin will be 22 IU/h.
干预措施: Oxytocin (Drug)
Oxytocin infusion rate 30 IU/h
The maintenance infusion rate of oxytocin will be 30 IU/h.
干预措施: Oxytocin (Drug)
Oxytocin infusion rate 34 IU/h
The maintenance infusion rate of oxytocin will be 34 IU/h.
干预措施: Oxytocin (Drug)
Oxytocin infusion rate 36 IU/h
The maintenance infusion rate of oxytocin will be 36 IU/h.
干预措施: Oxytocin (Drug)
结局指标
主要结局
Uterine tone up to discharge from the post anesthetic care unit (PACU): questionnaire
时间窗: 2 hours
Uterine tone will be evaluated as satisfactory or unsatisfactory by the obstetrician throughout the surgery, starting at 5 minutes after the oxytocin infusion. It will also be measured at 10 minutes following the oxytocin infusion and every 10 minutes following that for the duration of the surgery. Unsatisfactory uterine tone at any time until discharge from the PACU will be considered a failure of the maintenance infusion.
次要结局
- Presence of atrial fibrillation: ECG(2 hours)
- Hypotension: systolic blood pressure less than 80% of baseline(2 hours)
- Presence of chest pain: questionnaire(2 hours)
- Requirement for additional uterotonic medication from discharge from the PACU until 24 hours postpartum.(24 hours)
- Tachycardia: heart rate greater than 130% of baseline(2 hours)
- Presence of ventricular tachycardia: ECG(2 hours)
- Need for blood transfusion(24 hours)
- Requirement for additional uterotonic medication in the PACU(2 hours)
- Bradycardia: heart rate less than 70% of baseline(2 hours)
- Presence of nausea: questionnaire(2 hours)
- Presence of vomiting: questionnaire(2 hours)
- Presence of shortness of breath: questionnaire(2 hours)
- Presence of headache: questionnaire(2 hours)
- Calculated blood loss(24 hours)
- Episodes of bleeding postpartum(24 hours)
- Intraoperative requirement for additional uterotonic medication(1 hour)
- Hypertension: systolic blood pressure greater than 120% of baseline(2 hours)
- Presence of atrial flutter: ECG(2 hours)