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临床试验/NCT04200599
NCT04200599已完成不适用

Amniotomy and Early Oxytocin Infusion Versus Amniotomy and Delayed Oxytocin Infusion in Nulliparous Women: a Randomised Controlled Trial

National University of Malaysia0 个研究点目标入组 250 人开始时间: 2014年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
250
主要终点
Neonatal outcome

研究概览

简要总结

In UKM Medical Centre (UKMMC), delayed oxytocin augmentation at two hours following amniotomy is the routine obstetric practice in spontaneous or induced labour with intact membranes. This practice may potentially cause prolonged labour, extended labour room occupancy and increased maternal exhaustion while no additional benefit can be gained. On the other hand, recommendation for early oxytocin augmentation poses a dilemma as the effectiveness and safety of this practice are still in doubt.

Given this background, the aim of this study was to compare the effect of early versus delay oxytocin infusion in achieving successful vaginal delivery among the low-risk nulliparous women in UKMMC. Besides, this study also compares the adverse maternal and neonatal outcomes between the two practices.

详细描述

This was a randomised controlled trial undertaken in the labour room of UKMMC for a period of eighteen months from August 2014 until February 2016. Eligible women who were admitted in spontaneous labour or for induction of labour were recruited. For women who underwent induction of labour, an interval of at least six hours following vaginal prostaglandin before recruitment was mandatory to avoid overlapping effect of prostaglandin and oxytocin. Upon enrolment, each patient was given a study explanation and written consent was obtained.

The randomisation sequence, either to the early oxytocin group or the delayed oxytocin group, was generated using the computer randomisation program in block of two. Allocation to either arm of treatment was determined by the sequential opening of sealed numbered envelopes.

In the first arm of early oxytocin group, labour augmentation with oxytocin was started early following artificial ruptured of membrane(ARM). In the second arm of delayed oxytocin group, oxytocin augmentation was delayed at two hours after ARM and this practice is currently being used as standard protocol in this hospital to manage women in labour. In both arms,the infusion rate was doubled every 30 minutes to a maximum of 48 mL/h or until four to five moderate contractions per 10 minutes were achieved at which point the infusion rate was maintained. Continuous fetal heart rate monitoring was maintained throughout the intrapartum period. Vaginal examination was performed at four hours after ARM as well as when clinically indicated ie. abnormal cardiotocography (CTG) and maternal desire to bear down. In the presence of abnormal CTG, either fetal blood sampling or expedited delivery was undertaken as per decided by the obstetrician in charge.

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
Single (Participant)

入排标准

年龄范围
19 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •gestational age between 36+0 to 41+6 weeks
  • •singleton pregnancies in cephalic presentation
  • •estimated fetal weight between 2.5 - 4.0 kg
  • •cervical dilatation of 4 cm with intact membranes
  • •normal fetal heart rate trace before artificial rupture of membranes

排除标准

  • •Women with significant medical (eg. heart disease, pre-eclampsia, diabetes with high dose insulin, retroviral disease)
  • •fetal abnormality (eg. fetal growth restriction or small for gestational age < 2.5 kg, suspected macrosomia > 4.0 kg, fetal anomaly)

研究组 & 干预措施

Early oxytocin Infusion

Experimental

labour augmentation with oxytocin was started early following amniotomy.

干预措施: duration of initiation of oxytocin (Other)

Late oxytocin infusion

Active Comparator

oxytocin augmentation was delayed at two hours after amniotomny and this practice is currently being used as standard protocol in this hospital to manage women in labour.

干预措施: duration of initiation of oxytocin (Other)

结局指标

主要结局

Neonatal outcome

时间窗: through study completion, an average of 18 months

Apgar score

Achieving vaginal delivery

时间窗: through study completion, an average of 18 months

number of normal vaginal delivery

次要结局

未报告次要终点

研究者

发起方
National University of Malaysia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Azrai Abu

Clinical Consultant

National University of Malaysia

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