Effect of Increased Oxytocin Doses on the Mode of Delivery in Obese Primiparous Women With Spontaneous or Induced Labour. A Double-blind, Randomised, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 443
- 试验地点
- 12
- 主要终点
- Rate of caesarean section during labour
研究概览
简要总结
The rate of caesarean section is higher among obese pregnant women, leading to increased morbidity in this already vulnerable population. Oxytocin is the main drug used in obstetrics to optimize progress of labour, but observational studies have suggested that its efficiency may be insufficient in obese women with usual doses.
We design a randomised controlled trial to test the effect of an increased oxytocin dose on the rate of caesarean section in obese primiparous women with spontaneous or induced labour.
详细描述
The hypothesis underlying this trial is that an increase in oxytocin dose can reduce the rate of caesarean sections in primiparous obese patients, with a spontaneous or induced onset of labour, without increasing maternal or neonatal morbidity. This would be a major step forward in reducing morbidity in an at-risk population and in improving the obstetric prognosis for future pregnancies.
The research is a double-blind controlled trial, including primiparous obese women in spontaneous or induced labour, for whom a prescription of oxytocin is decided. Oxytocin is currently indicated for notably "insufficiency of uterine contractions, at the beginning or during labour".The recommended dosage in the market authorization will be used for the control group.
The control group will receive oxytocin at 2 milli-International unit /mL and the intervention group at 4 milli-International unit /mL, controlled by pump (final volume = 500 mL) or electrical syringe (final volume = 50 mL).
The primary objective is to compare the effect of higher doses of oxytocin (intervention group) vs standard doses of oxytocin (control group) on the rate of caesarean sections in obese patients with spontaneous or induced onset of labour.
The secondary objectives will be to compare the effect of higher doses of oxytocin (intervention group) vs standard doses of oxytocin (control group) on maternal and labour complications (length of labour, arrest of labour, interruption of oxytocin perfusion and reason, uterine hyper-stimulation, mode of vaginal delivery, reason for caesarean section, post-partum haemorrhage, maternal blood transfusion, volume of oxytocin infusion, oxytocin side effects), as well as foetal complications and neonatal complications.
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)
盲法说明
An "out-of-protocol" healthcare professional (midwife / nurse) will prepare oxytocin. The "out-of-protocol" healthcare professional (midwife / nurse) will not be a study's investigator, and will not be involved in the patient's care. The randomization group will not be communicated to the investigator or any medical personnel involved in the study or patient by the "out-of-protocol" nurse/midwife, in order to preserve the double-blind design.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Experimental group
The experimental group will receive oxytocin at 4 mIU/mL
干预措施: Oxytocin 4 mIU/mL (Drug)
Control group
The control group will receive oxytocin at 2 mIU/mL
干预措施: Oxytocin 2 mIU/mL (Drug)
结局指标
主要结局
Rate of caesarean section during labour
时间窗: through study completion, an average of 1 month
The decision of caesarean section is made by the responsible obstetrician in charge of the patient, he or she will be blinded of the patient's group (oxytocin dosage) to avoid differential indication for caesarean section. Therefore, the decision to perform (or not) a caesarean section will be only based on foetal/maternal criteria, independently of oxytocin dosage.
次要结局
- Length of labour phases(Through study completion, an average of 1 month)
- Arrest of labour(Through study completion, an average of 1 month)
- Interruption of oxytocin perfusion and causes(through study completion, an average of 1 month)
- Uterine hyper-stimulation(Through study completion, an average of 1 month)
- Mode of vaginal delivery(Through study completion, an average of 1 month)
- Reason for the caesarean section(through study completion, an average of 1 month)
- Post-partum haemorrhage(Through study completion, an average of 1 month)
- Maternal blood transfusion(Through study completion, an average of 1 month)
- Volume of oxytocin infusion(Through study completion, an average of 1 month)
- Oxytocin side effects(Through study completion, an average of 1 month)
- Foetal complications(Through study completion, an average of 1 month)
- Neonatal complications(Through study completion, an average of 1 month)