Effect Of Intravenous Hyoscine -N-Butyl Bromide In Management Of Prolonged Labor In Nulliparous
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- the duration of active phase of first stage of labor
研究概览
简要总结
Women will be admitted when active phase of labour starts defined as the presence of at least three regular uterine contractions over 10 minutes with cervical dilatation four centimeters with cervical effacement not less than 50% and no progress of labor for 2 hours or more.
Amniotomy was done in those with intact membrane and continuous electronic fetal monitoring was done. Women with prolonged labor after these measures were randomly divided using automated web-based randomization system into 2 equal groups. Group I included 50 women received 40mg HBB (Buscopan, Memphis Co, Giza, Egypt) intravenous bolus injection. Group II included 50 women received 2 ml of normal saline. The obstetrician, participants and outcome assessor were all blinded to the group assignment. Labor will be monitored by Vaginal examination every two hours. The duration of the first stage was calculated from the time of cervical dilatation of three to four centimeters in active labor until a fully dilated cervix was observed.
详细描述
Women will be admitted when active phase of labour starts defined as the presence of at least three regular uterine contractions over 10 minutes with cervical dilatation four centimeters with cervical effacement not less than 50% and no progress of labor for 2 hours or more.
Amniotomy was done in those with intact membrane and continuous electronic fetal monitoring was done. Women with prolonged labor after these measures were randomly divided using automated web-based randomization system into 2 equal groups. Group I included 50 women received 40mg HBB (Buscopan, Memphis Co, Giza, Egypt) intravenous bolus injection. Group II included 50 women received 2 ml of normal saline. The obstetrician, participants and outcome assessor were all blinded to the group assignment. Labor will be monitored by Vaginal examination every two hours. The duration of the first stage was calculated from the time of cervical dilatation of three to four centimeters in active labor until a fully dilated cervix was observed.
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)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• Nulliparous women.
- •cervical dilatation in the active phase of less than 1.2 cm/h for nulliparous women
- •Gestational age ≥ 37 weeks.
- •Singleton pregnancy.
- •Vertex presentation.
- •Cervical dilatation ≥ 4cm.
- •No evidence of maternal or fetal distress.
- •Average size baby.
排除标准
- •History of cervical surgery.
- •Mal-presentation and mal-positions.
- •Hypersensitivity to Hyoscine.
- •Contraindication for vaginal delivery.
研究组 & 干预措施
Hyoscine group
- Group A will receive injection Hyoscine butyl bromide 40 mg single intravenous dose
干预措施: Hyoscine N Butylbromide (Drug)
Control group
Group B, will receive 2 ml of normal saline single intravenous dose
干预措施: Normal Saline 0.9% (Drug)
结局指标
主要结局
the duration of active phase of first stage of labor
时间窗: 8 hours after hyoscine adminstration
time elapsed between start of active phase till full cervical dilatation
次要结局
未报告次要终点
研究者
Ahmed M Maged, MD
professor
Cairo University