A Randomised Control Study: The Effect of Hyoscine-N-butylbromide (HBB, Buscopan) in Augmented Labour Among Primigravidae
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Labor length
研究概览
简要总结
This study compares the duration of active phase of labour in women who received buscopan and those who don't.
详细描述
A randomised control study involving primigravida in labour who require pitocin augmentation. Once patient require augmentation, patient will be randomised into intervention group (receiving intravenous buscopan 1ml or 20mg) and control group (intravenous normal saline 1ml). Both fluids are colourless. The primary outcome is duration from augmentation to os fully. The secondary outcome are to look on mode of delivery particularly any caesarean section due to failure to poor progress, maternal side effect (dry mouth and tachycardia) and baby outcome (apgar score and neonatal intensive care unit admission)
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
- Double (Participant, Care Provider)
盲法说明
Participants and care provider are blinded from the treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Primigravida
- •Vertex presentation
- •Term gestation (37-41w)
- •Active phase of labor (4cm with regular contraction at least 2:10)
- •Spontaneous labor
- •Oxytocin augmentation
- •Maternal height ≥150cm
排除标准
- •Multiple pregnancies
- •Previous uterine surgery
- •Hypertensive disease in pregnancy
- •Gestational diabetes on treatment
- •Clinical estimation of fetal weight >3.8kg
- •Induction of labor
- •Meconium stained liquor
- •Allergy to hyoscine
- •Medical contraindication to hyoscine (i.e Myasthenia gravis, glaucoma, megacolon)
研究组 & 干预措施
Hyoscine
Participants receive intravenous bolus of 1ml (20 mg) Hyoscine
干预措施: Hyoscine Butylbromide (Drug)
Placebo
Participants receive intravenous bolus of 1ml normal saline
干预措施: Placebo (Other)
结局指标
主要结局
Labor length
时间窗: Through study completion until delivery up to 12 hours
Duration of labor
次要结局
- Blood loss(Through study completion up to 42 days after delivery)
- Pain score(Pre-intervention)
- Pain score 6 hours(From time of intervention up to 6 hours after)
- Neonatal intensive care unit admission(From delivery of neonate up to 30 days)
- Side effects(Through study completion up to 42 days after delivery)
- Pre-pregnancy body mass index(At the time of recruitment)
- Neonatal outcome 5 minute(From delivery of neonate up to 5 minutes after)
- Maternal age(At the time of recruitment)
- First stage of labor(From onset of regular contraction to cervical dilatation of 10 cm up to 24 hours)
- Second stage of labour(From cervical dilatation of 10cm until delivery of fetus)
- Third stage of labour(From delivery of fetus until delivery of placenta)
- Mode of delivery(Through study completion up to 12 hours)
- Neonatal outcome 1 minute(From delivery of neonate up to 1 minute after)
- Gestational age(At the time of recruitment)
- Pain score 2 hours(From time of intervention up to 2 hours after)
- Analgesia(Through study completion until delivery up to 12 hours)
- Pain score 4 hours(From time of intervention up to 4 hours after)
研究者
Rahana Abd Rahman
Co-primary investigator
National University of Malaysia