Use of Antispasmodic Drotaverine to Shorten the Length of Labor in Nulliparous Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- Duration of the active first stage of labor
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 along, protracted labor entails shorter exposure to pain, anxiety and stress and would thus translate into a major improvement in maternal satisfaction with the childbirth experience.
Based on the premise that shortening the length of labor is beneficial, interventions aimed at accelerating the progression of labor have been introduced routinely as part of standard labor management and care throughout the 20th century. Certain labor accelerative procedures, such as amniotomy, became common practice and have been put to the acid test of randomized control trials to evaluate their efficacy. Use of anticholinergics/antispasmodics as a method of augmenting 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 atropine-like drug (Syntropan®)mainly among older nulliparas.
Drotaverine, an isoquinolone derivative is a superior smooth muscle relaxant which acts specifically on spastic sites and corrects the cAMP and calcium balance relieving smooth muscle spasm.
This inhibitory action is detected only in lower uterine segment during labor since muscle fibers in upper uterine segment are strongly affected by contractile effect of oxytocin. Use of drotaverine during pregnancy is free of any teratogenic and embryotoxic effects.
The Research question is: Does the use of antispasmodic Drotaverine shorten the duration of active first stage of labor in nulliparous women as compared to placebo?
详细描述
Research question:
Does the use of antispasmodic Drotaverine shorten the duration of active first stage of labor in nulliparous women as compared to placebo?
Research hypothesis: the population means of the Drotaverine and placebo groups are equal regarding the duration of the first stage of labor.
Objectives:
The purpose of this study was to determine the effectiveness of Drotaverine for reducing the duration of labor for the context of contemporary practice, 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
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged between 18 and less than 35 years.
- •Primigravidae.
- •Singleton pregnancy.
- •Term gestation i.e., 37-42 weeks.
- •Sure, reliable dates documented by ultrasound in the 1st half of pregnancy.
- •Vertex presentation with occipito anterior position
- •Regular uterine contractions at a rate of at least 3 to 4 contractions every 10 minutes, each contraction lasting for at least 40 seconds.
- •Cervical dilatation of 3-5 cm.
- •With or without rupture of membranes
- •No evidence of maternal or fetal distress.
排除标准
- •Cephalo-pelvic disproportion.
- •Cervical surgery in the past or history of cervical injury.
- •Patients on antihypertensive therapy.
- •Known hypersensitivity to Drotaverine hydrochloride.
- •If any other spasmolytic agent had been used within 48 hours.
研究组 & 干预措施
Drotaverine
Women who will receive 40 mg Drotaverine hydrochloride (Do-Spa) IV injection.
干预措施: Drotaverine (Drug)
Placebo
Women who will receive 2ml of normal physiological saline (0.9% sodium chloride) I.V.
干预措施: Placebo (Drug)
结局指标
主要结局
Duration of the active first stage of labor
时间窗: 12 hours
次要结局
- Rate of cervical dilation (cm/h)(12 hours)
- Effect on pain by using visual analogue scale(12 hours)
- Mode of delivery(12 hours)
- APGAR score less than 7 at 1 and 5 minutes(12 hours)
研究者
Mohammed Abd El Hameed Abd El Lateef
Investigator, Obstetrics and Gynaecology
Ain Shams Maternity Hospital