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临床试验/NCT01937234
NCT01937234已完成4 期

Use of an Antiemetic to Shorten the Length of Labor in Nulliparous Women, Exploring a Potential Role of an Old Drug

Ain Shams University1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2013年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
250
试验地点
1
主要终点
Cervical dilatation rate

研究概览

简要总结

Reducing the length of labor is a highly desirable goal of intrapartum care, both from a perspective of maternal and fetal well-being , and for the providers of the birth services. Avoiding a long , protracted labor entails shorter exposure to pain anxiety and stress and would translate into a major improvement in maternal satisfaction with the child birth experience.

The purpose of this study is to determine the effectiveness of metoclopramide for reducing the duration of spontaneous labor among nulliparous women managed according to a standard intrapartum protocol.

详细描述

Women who will fulfill the study inclusion and exclusion criteria and agree to be included in the study will be randomized assigned to receive either an intravenous injection of 10mg metoclopramide (Group 1) or the same volume of placebo, i.e. 0.9% sodium chloride (Group2). Randomization will be achieved using computer generated randomization sequences. Allocation will be in 1:1 ratio. Record of group allocation will be maintained by a resident physician whose responsibility is randomization and drawing up the injection, but has no direct involvement in the intrapartum decision making.

After through history and physical examination, each participant will take the selected medication slowly IV over 2 min, the assigned medication will be repeated every two hours for a maximum of three doses.

Monitoring of fetal well-being and labor progress with Partographic representation will be performed.

Management of labor will be according the labor and delivery standard protocol, if labor dilatation will not progress appropriately, i.e. cervical dilatation rate of <1cm/hour, amniotomy will be performed if membranes are intact. Oxytocin augmentation will be considered after rupture of membranes only if the cervix remains unchanged on two consecutive pelvic examination conducted two hours apart. Oxytocin infusion will start with 5mIU/min and increase by 5mIU/min every 15min to achieve seven contractions in 15 min, the maximal rate of oxytocin being 30Miu/min.

The following parameters will be recorded for every patient:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

  • Primigravida
  • Singleton pregnancy
  • Term gestation i.e. 37- 42 weeks
  • Sure reliable dates
  • Vertex presentation, occipitoanterior position
  • Spontaneous onset of labor
  • Regular uterine contractions at every 5 min ,each lasting for 20 sec
  • Cervical dilatation of 3-5cm
  • With or without rupture of membranes
  • No evidence of maternal or fetal distress

排除标准

  • Mal-presentations
  • Mal-positions
  • Multifetal pregnancy
  • Cephalopelvic disproportion
  • history of cervical surgery or injury
  • Hypersensitivity to metoclopramide

研究组 & 干预措施

Metoclopramide

Active Comparator

Intravenous injection of 10mg metoclopramide

干预措施: Metoclopramide (Drug)

Placebo

Placebo Comparator

Intravenous injection of 0.9% sodium chloride

干预措施: Placebo (Drug)

结局指标

主要结局

Cervical dilatation rate

时间窗: 6 hours

次要结局

  • Duration of the first stage of labor(6 hours)

研究者

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

Mohamed Ellaithy

Lecturer of Obstetrics & Gynecology

Ain Shams University

研究点 (1)

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