The Effect of Metoclopramide on the Length of First Stage of Labor in Nulliparous Women, a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- duration of labour
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 childbirth experience.
Prolonged labor can lead to increased maternal and neonatal morbidity and mortality such as rupture of the uterus, postpartum hemorrhage, puerperal sepsis, and maternal death. Prolonged labor may be due to maternal age, premature rupture of membrane, epidural analgesia and the secretion of high levels of maternal stress hormones.
详细描述
Several studies showed that active management of labor could shorten the duration of labor, and the safety of this method has been demonstrated.
Metoclopramide binds to dopamine receptors acting as a receptor antagonist, and it is also a mixed serotonin receptor agonist and antagonist.
Metoclopramide could potentially reduce spasms of the smooth muscle of the cervix that remains richly innervated at birth and thus have a regulatory effect on cervical contractility, an interaction that might be important in aiding maximal tissue compliance, promoting cervical dilatation during labor, and helping to reduce dystocia. Dopamine and other catecholamines have been identified in rabbit, rat, guinea-pig, sheep, and human uteri.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •primigravida
- •singleton pregnancy
- •termgestation (37-42 weeks)
- •sure reliable dated
- •vertex presentation , occipito-anterior position
- •regular uterine contractions at every 5 minutes,each lasting for 20 seconds
- •cervical dilatation of 5 cm
- •with or without rupture of membrane
- •no evidence of maternal or fetal distress
排除标准
- •chorioamnionitis
- •scarred uterus e.g. myomectomy
- •cephalopelvic dispropotion
- •history of cervical surgery or injury
- •hypersensitivity to metoclopramide
研究组 & 干预措施
(group 1) receiving intravenous metoclorpramide
this group receive 10mg intravenous metoclopramide
干预措施: Metoclopramide 10mg (Drug)
(group 2) receiving placebo
this group receive 10mg intravenous placebo(0.9 sodium chloride)
干预措施: Placebo (0.9 sodium chloride) (Drug)
结局指标
主要结局
duration of labour
时间窗: 8-12 hours
cervical dilatation rate in first stage of labour
次要结局
- labour pain(pain assessment at 30,60,120 minutes following injection of metoclopramide)
研究者
Shaimaa Mostafa Mohammed Refaay El shemy
Lecturer of Obstetrics and gynecology at Cairo university
Cairo University