The Effect of the Ritgen Maneuver on Perineal Trauma During the Second Stage of Labor: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Incidence of Perineal Trauma
研究概览
简要总结
Perineal trauma is one of the common complications that may occur during the second stage of labor and can negatively affect women's postpartum recovery and quality of life. The Ritgen maneuver is a hands-on perineal protection technique performed during fetal head delivery to control the birth of the fetal head and potentially reduce perineal injury. However, evidence regarding its effectiveness remains inconsistent.
This randomized controlled trial aims to evaluate the effect of the Ritgen maneuver on perineal trauma during the second stage of labor. Pregnant women admitted for vaginal birth will be randomly assigned to either the Ritgen maneuver group or the standard care group. The incidence and degree of perineal trauma, episiotomy, and related maternal outcomes will be compared between groups.
The findings of this study are expected to contribute to the evidence base regarding perineal protection techniques during vaginal birth and support the development of clinical practices aimed at reducing birth-related perineal trauma
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women aged 20 years or older.
- •Gestational age ≥37 weeks.
- •Singleton pregnancy.
- •Cephalic (vertex) presentation.
- •Planned vaginal birth.
- •No perineal massage during the last 4 weeks of pregnancy.
- •Not regularly engaged in active sports activity.
- •Willing to participate and provide informed consent
排除标准
- •Fetal anomaly.
- •Human papillomavirus (HPV) infection.
- •Herpes simplex virus (HSV) infection.
- •Presence of perineal edema.
- •Vulvar varicosities.
- •Opioid administration during labor.
- •Prolonged labor.
- •Labor dystocia.
- •Development of fetal distress during labor.
- •Instrumental vaginal delivery (vacuum, Kiwi, or forceps-assisted delivery)
结局指标
主要结局
Incidence of Perineal Trauma
时间窗: Immediately after birth
The occurrence of any perineal trauma following vaginal birth, including spontaneous perineal lacerations and episiotomy-related perineal injury.
次要结局
- Postpartum Pain Score(Within 2 hours after birth)
研究者
Gözde Küğcümen
Assistant Professor, Ph.D.
Medipol University