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临床试验/NCT02839213
NCT02839213已完成2 期

The Effect of Hyoscine Butylbromide on Shortening of First and Second Stages of Labor

Woman's Health University Hospital, Egypt1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
400
试验地点
1
主要终点
The time of first and second stages of labor

研究概览

简要总结

The management of normal labor is both an art and a science. For decades, health providers have worked to manage labor actively and safely, with the goal of shortening the duration of painful labor. Reduction of Cesarean sections and other fetal and maternal complications is also an important aspect of labor management.

The safety of active management of labor has been demonstrated by several prospective randomized clinical trials. A shorter duration of labor from admission to delivery has also been consistently reported in numerous studies of women treated with the active management protocol.Hyoscine butylbromide belongs to the parasympatholytic group of drugs and is a semisynthetic derivative of scopolamine. It is an effective antispasmodic drug without the untoward side effects of atropine. Hyoscine butylbromide is a quaternary ammonium compound and has peripheral anticholinergic action, but no central action as it does not cross the blood-brain barrier. Hyoscine butylbromide acts primarily by blocking the transmission of neural impulses in the intraneural parasympathetic ganglia of abdominal organs, apparently inhibiting cholinergic transmission in the synapses of the abdominal and pelvic parasympathetic ganglia, thus relieving spasms in the smooth muscles of gastrointestinal, biliary, urinary tract, and female genital organs, especially the cervico-uterine plexus, thus aiding cervical dilatation.

Spasmolytic drugs are frequently employed in delivery rooms to overcome cervical spasms and thus reduce the duration of labor.

Hyoscine butyl bromide has been used to shorten the duration of labor in several hospitals in the world. The mechanism by which it acts in the context of labor has not yet been elucidated, and evidence of its efficacy has been largely anecdotal.

Major studies have been carried out to evaluate the effects of the injectable or suppository form of Hyoscine butyl bromide on cervical dilatation; a majority of these studies demonstrated the efficacy of Hyoscine butyl bromide in augmenting labor. However, a few studies showed no effect of Hyoscine Butyl bromide on accelerating labor. In addition, some studies also used oxytocin in active management of labor, which would certainly affect the duration of labor and increase bias in the results. The specific objectives of this study will be to assess whether Hyoscine butyl bromide is effective in hastening cervical effacement and dilatation, thus shortening the duration of the first and second stages of labor with or without labor augmentation. We also intended to determine whether the use of Hyoscine butyl bromide in the first and second stages of labor has any associated increases in complications, such as an increase in blood loss or the rate of cesarean deliveries.

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, Investigator)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • All 18 -40 years.
  • Singleton pregnancies.
  • Vertex presentation.
  • Term (gestational age between 37-41 weeks + 6 days).
  • Spontaneous labor with either intact membranes or spontaneous rupture of membranes for less than 12 hours.

排除标准

  • Previous uterine scarring including previous cesarean section.
  • Cephalopelvic disproportion.
  • Malpresentation.
  • Antepartum hemorrhage.
  • Multiple pregnancy.
  • Induced delivery.
  • Any medical disease.
  • Prolonged premature rupture of the membrane (more than 12 hours).
  • Epidural analgesia or receive any analgesic like pethidine.
  • Pervious cervical cerclage.

研究组 & 干预措施

group A (Hyoscine Butyl bromide group)

Active Comparator

The women will be given Hyoscine Butyl bromide

干预措施: Hyoscine Butyl bromide (Drug)

group B (Saline group)

Active Comparator

The women will be given saline

干预措施: Saline (Drug)

结局指标

主要结局

The time of first and second stages of labor

时间窗: 8 hours

次要结局

未报告次要终点

研究者

发起方
Woman's Health University Hospital, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kamal Mohamed Zahran

Prof

Woman's Health University Hospital, Egypt

研究点 (1)

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