Valethamate Bromide Versus Hyoscine Butyl Bromide in Reducing Labour Duration Among Primigravida: A Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Rate of cervical dilatation
研究概览
简要总结
Labour is a physiological process that enables the natural delivery of fetus, placenta and membranes after the age of viability.
This study compared the efficacy of valethamate bromide and hyoscine butyl bromide in reducing labour duration among primigravid women at Alex Ekwueme Federal University Teaching Hospital, Abakaliki
详细描述
Labour is a physiological process that enables the natural delivery of fetus, placenta and membranes after the age of viability. When labour is prolonged, it may defeat the whole essence of pregnancy as a result of poor outcome. Efforts have been made to prevent prolonged labour which includes the use of certain medications such as hyoscinebutyl bromide and valethamate bromide. However, there is paucity of studies comparing the effectiveness of both drugs, which could provide a better choice of reducing labour duration and its attendants' complications.
AIM:
This study compared the efficacy of valethamate bromide and hyoscine butyl bromide in reducing labour duration among primigravid women at Alex Ekwueme Federal University Teaching Hospital, Abakaliki.
RESEARCH METHOD:
This was a randomized controlled study where equal members of primigravid women at term were recruited and received 8 mg (2 ml) of valethamatebromide;20 mg (2 ml) of hyoscine butyl bromideand 2ml of sterile water.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Primigravidae / nulliparae.
- •Singleton term pregnancy with no evidence of maternal or fetal distress.
- •Women with fetus in cephalic presentation.
- •Age: 18- 35 years.
- •Women with no contra-indications to vaginal delivery.
- •Cervical dilatations of 4- 9cm when in labour
- •Spontaneous or induced labour.
- •Patients on epidural analgesia
排除标准
- •Multiple gestations.
- •Women with abnormal fetal presentation.
- •Absolute indications for caesarean section.
- •Antepartum hemorrhage.
- •Evidence of maternal or fetal distress.
- •Fibroid in pregnancy.
- •Grand multiparous patients.
- •Previous uterine scar/ surgery or ruptures.
- •Medical disorders of pregnancy like pre-eclempsia, Eclempsia, Dm etc.
- •If any other antispasmodics agent had been used within the last 48 hours.
- •Preterm/ term premature rupture of membranes.
- •History of cervical injury/ surgery.
- •Hypersensitivity to valethamate bromide and/or hyoscine butyl bromide
研究组 & 干预措施
Valethamate
Group I received 2ml (16mg) of valethamate bromide intravenously, when patient is in active phase of labour.
干预措施: Valethamate Bromide (Drug)
Hyoscine
Group II received 2ml (40mg) of hyoscine butyl bromide intravenously when patient is in active phase of labour.
干预措施: Hyoscine butylbromide (Drug)
Water
Group III received 2ml of sterile water for injection when patient is in active phase of labour
干预措施: Sterile water (Other)
结局指标
主要结局
Rate of cervical dilatation
时间窗: 8hours
This was the rate of dilation of the cervix per hour in patients in active phase of labour
次要结局
未报告次要终点
研究者
Assumpta Nnenna Nweke
Principal Investigator
Federal Teaching Hospital Abakaliki