Selective Use of Episiotomy: the Impact on Perineal Trauma. A Prospective Observational Study Based on a New Classification of Perineal Trauma.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Overall Incidence of perineal trauma
研究概览
简要总结
Vaginal delivery is commonly accompanied by trauma of the genital tract. Perineal trauma is classified into four degrees based on anatomic structures involved and severity of lacerations according to the American College of Obstetricians and Gynaecologists (ACOG) and the Royal College of Obstetricians and Gynaecologists (RCOG). Episiotomy is an intentional perineal incision performed by midwifes or obstetricians to enlarge vaginal opening during the second stage of childbirth and has become the most common surgical procedure worldwide. A routine use of episiotomy was proposed to prevent severe spontaneous lacerations, although it failed to to demonstrate a clear protective role with no benefits both for mother and baby. Therefore the guidelines changed in a selective use of episiotomy, and we have introduced it in our routine obstetrics care. Nevertheless, second-degree lacerations comprise a wide range of lesions, from a minimal involvement to a massive damage of the perineal muscles. Therefore, it was never confirmed that selective use of episiotomy reduce the perianal trauma in the range of second degree lesions.
We designed a prospective observational study with the introduction of a new classification of perineal trauma recorded with the usual data retrieved in delivery ward register. The aim is to definitively investigate if selective use of episiotomy reduce the overall perineal trauma.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Vaginal delivery
排除标准
- •All situations in which episiotomy was recommended according to our Labour Ward's procedures (such as shoulder dystocia, breech presentation and operative delivery with vacuum) have been excluded.
结局指标
主要结局
Overall Incidence of perineal trauma
时间窗: At delivery
Overall Incidence of perineal trauma
Incidence of different degree of perineal trauma
时间窗: At delivery
Incidence of different degree of perineal trauma
Incidence of different subgroup of second-degree perineal trauma
时间窗: At delivery
Incidence of different subgroup of second-degree perineal trauma based on new classification
次要结局
未报告次要终点
研究者
Simone Garzon
Principal Investigator
Universita di Verona
