A Randomised Double Blind Clinical Trial to Verify if Perineal Massage Increases the Chances of Delivering With an Intact Perineum Comparing the Two Oils. As Secondary Objective, we Will Evaluate the Effects of Perineal Massage on Specific Tear Location, the Severity of Perineal Tears and the Amount of Suture Material Required for Repair
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- perineal tears vs intact perineum
研究概览
简要总结
In this study we intend to randomly assign each parturient one of two commonly used oils to be applied during the second stage of labor, one of them containing vitamin E. We will verify if perineal massage increases the chances of delivering with an intact perineum comparing the two oils. As secondary objectives, we will evaluate the effects of perineal massage on specific tear location, the severity of perineal tears and the amount of suture material required for repair.
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
- Double (Participant, Care Provider)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancy
- •Term pregnancy
排除标准
- •Non-vertex pregnancies
- •Multiple pregnancies
- •Placenta previa
- •Placental abruption
- •Intra-uterine infection
- •Non progressive labor first stage
- •Former operations or surgical procedures in the vagina
- •Perineal massage during the weeks before labor
研究组 & 干预措施
A
parturients during the second stage of labor massaged by Wheat Germ Oil
干预措施: perineal massage with Wheat Germ Oil during the second stage of labor (Other)
B
parturients during the second stage of labor massaged by almond oil
干预措施: perineal massage with almond oil during the second stage of labor (Other)
结局指标
主要结局
perineal tears vs intact perineum
时间窗: after delivery
次要结局
- severity of perineal tears amount of suture material required for repair suturing length(after delivery)