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临床试验/NCT01854073
NCT01854073Unknown3 期

Use of Hyoscine Butyl Bromide for Management of Prolonged Labor in Nulliparous Women, A Randomized Controlled Trial

Ain Shams University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2014年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
500
试验地点
1
主要终点
Caesarean section rate for failure to progress

研究概览

简要总结

To determine the value of using Hyoscine as an antispasmodic drug for the management of prolonged labor in nulliparous women at term.

详细描述

Management of prolonged labor represents a challenging area in the daily obstetric practice. In 1993, Handa and Laros defined the arrest of active phase of labor, as failure of labor progress for 2 hours or more, and in 1994, WHO has proposed labor management partograph in which protraction is defined as < 1cm/hour cervical dilatation for a minimum of 4 hours.

Prolong labor increase the risks of maternal exhaustion, postpartum hemorrhage, sepsis, fetal distress and admission to the neonatal intensive care unit. The treatment of prolonged labor is highly desirable goal of intrapartum care, both from prospective of maternal and fetal wellbeing and for the provider of the birth services. Management of prolonged labor entails shorter exposure to pain, anxiety, and stress, and would thus translate into a major improvement in maternal satisfaction with child birth experience.

Several methods have been used for management of prolonged labor including amniotomy and oxytocin. Amniotomy can cause infection, and can be combined with oxytocin for better results while oxytocin can cause uterine hyper stimulation, water intoxication, vomiting, diarrhea, fetal distress, and neonatal jaundice.

Use of antispasmodics for reducing the duration of labor was first described in 1937 by Hirsch, who reported a decrease in labor length by two to four hours following intrapartum administration of an antispasmodic like drug (Syntropan®), mainly among older nulliparous, this was followed by many studies that investigated the role of antispasmodics in prevention of prolonged labor, however none of the these studies assessed the value of the antispasmodic for the treatment of prolonged labor; a recent Cochrane review advised that a rigorously designed well conducted randomized controlled trial with a large sample size would be beneficial to answer the question.

Hyoscine butyl bromide is spasmolytic drug that act by competitive antagonism to acetyl choline at post ganglionic parasympathetic nerve ending. It is claimed to reduce duration of labor by accelerating cervical dilatation without major side effects. It reduces the spasm of the smooth muscles. Although the efficacy of Hyoscine has been proven in various studies there is no clear evidence to recommend their routine use in management of prolonged labor.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Nulliparous women.
  • Prolonged labor defined as no progress of labor for 2 hours or more.
  • Gestational age ≥ 37 weeks.
  • Singleton pregnancy.
  • Cephalic presentation.
  • Cervical dilatation ≥ 5 cm.
  • Intact fetal membranes.
  • No evidence of maternal or fetal distress.
  • Average size baby.

排除标准

  • Multigravid women.
  • Multifetal pregnancy.
  • History of cervical surgery.
  • Blood pressure > 150/90 mmHg.
  • Mal-presentation and mal-positions.
  • Hypersensitivity to Hyoscine.
  • Contraindication for vaginal delivery.

研究组 & 干预措施

Group A

Active Comparator

Group A, will receive injection Hyoscine butyl bromide 20 mg first dose at the time of amniotomy, and second dose 2 hours after.

干预措施: Hyoscine butyl bromide (Drug)

Group B

Placebo Comparator

Group B, will receive normal saline same volume first dose at the time of amniotomy, and second dose 2 hours after.

干预措施: Normal saline (Drug)

结局指标

主要结局

Caesarean section rate for failure to progress

时间窗: 6 hours

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Ellaithy

Assistant professor of Obstetrics & Gynecology

Ain Shams University

研究点 (1)

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