ACTRN12607000631404终止4 期
A double-blind randomised controlled trial of oxytocin bolus plus placebo infusion versus oxytocin bolus plus oxytocin infusion for the prevention of uterine atony and post partum haemorrhage at elective caesarean section.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 948
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 45 Years(—)
- 性别
- Female
入选标准
- •Pregnancy: Singleton only Fetus: Alive only Gestation: 37 weeks - 41 weeks Surgery: Elective lower segment caesarean section Anaesthesia: Regional anaesthesia (spinal, epidural, combined spinal epidural (CSE)) Past medical history: No significant maternal medical or obstetric disorders Parity: <3 (equal to or less than 3): Pre-op Haemoglobin: Hb > (equal to or more than) 100g/dl Language: Fluency in English Age: >18 years of age (equal to or more than)
排除标准
- •Active labour (presence of regular uterine activity accompanied by cervical dilation)
- •Emergency caesarean section
- •General anaesthesia
- •(Less than) <37 completed weeks of pregnancy
- •Fetal demise
- •Multiple pregnancy
- •Polyhydramnios
- •Macrosomic fetus (Estimated fetal weight EFW >4.5 kg)
- •Past history of post partum haemorrhage 'PPH' requiring additional measures
- •Antepartum haemorrhage (requiring hospitalisation)
- •Known abnormality of placentation (e.g. placenta praevia, vasa, praevia, accreta)
- •Presence of uterine leiomyoma
- •Classical uterine incision (Past history of or intention at this lower segment caesarean section LUSCS).
- •Evidence of intrauterine infection e.g. chorioamnionitis
- •Significant maternal medical disorders: Cardiac disease/arrhythmias. Hypertensive disorders: chronic/essential hypertension /pregnancy induced hypertension PIH/Pre eclampsia +/- magnesium sulphate MgSO4 therapy. Known inherited coagulopathies, haemorrhagic/bleeding disorders (family history/known carriers of same) or other abnormalities of coagulation. Currently prescribed anticoagulant medication. Obstetric cholestasis. Connective tissue disorders
- •Past history of ruptured uterus
- •Previous adverse reaction to oxytocin (Syntocinon®)
研究者
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