Perineal Massage During Labor for the Prevention of Perineal Trauma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 466
- 试验地点
- 2
- 主要终点
- Incidence of perineal trauma (laceration or episiotomy) during vaginal delivery
研究概览
简要总结
The purpose of this study is to evaluate whether perineal massage during labor can help prevent perineal trauma, such as lacerations or episiotomies.
The study will test two hypotheses:
Null hypothesis: Perineal massage during labor does not prevent perineal trauma.
Alternative hypothesis: Perineal massage during labor helps prevent perineal trauma.
Participants will be randomly assigned to one of two groups:
Perineal massage group: Participants will receive perineal massage during labor.
Control group: Participants will receive the standard care provided by the labor and delivery unit.
A randomization process will be used to assign participants to each group.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients currently in labor
- •Gestational age between 37 and 42 weeks
- •Fetus presenting in cephalic position
- •No prior perineal massage performed during prenatal care
排除标准
- •Patients who progress to cesarean delivery
- •Diagnosis of HELLP syndrome
- •Unstable vital signs of the laboring woman or fetus
研究组 & 干预措施
Perineal Massage Group
The perineal massage group will receive the intervention during labor.
干预措施: Perineal massage (Procedure)
Control Group
The control group will receive the standard care provided by the obstetric center.
结局指标
主要结局
Incidence of perineal trauma (laceration or episiotomy) during vaginal delivery
时间窗: At the time of delivery
The presence and degree of perineal trauma will be assessed after delivery by the attending healthcare provider. Trauma will be classified by the presence of spontaneous perineal lacerations (graded I to IV) and/or performance of episiotomy.
次要结局
未报告次要终点
研究者
Gabriela Plentz Stein
Researcher
Federal University of Rio Grande do Sul