Short and Long Term Outcomes of Patients With and Without Pre-marked Episiotomy Location
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Third- and fourth-degree perineal tears
研究概览
简要总结
To compare short- and long-term outcomes of women following episiotomy during the second stage of labor, following marking of episiotomy location during the first stage of labor with those of women who underwent episiotomy without marking.
详细描述
Purpose: To compare short- and long-term outcomes of women following episiotomy during the second stage of labor, following marking of episiotomy location during the first stage of labor with those of women who underwent episiotomy without marking.
Hypothesis
Women following episiotomy following pre-marking of the location will suffer from fewer short- and long-term complications compared to those without pre-marked episiotomy location.
Study type: prospective randomized-controlled trial
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 (Participant)
盲法说明
Patients' data recorded according to a coding system
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women 18 years of age or older who present in active labour to our center and consent to participate in the study
排除标准
- •women under 18 years of age or those who do not or are unable to provide informed consent to participate in the study
结局指标
主要结局
Third- and fourth-degree perineal tears
时间窗: Up to 2 hours following the episiotomy
Perineal tears involving the anal sphincter in addition to the episiotomy, as documented in hospital records
Requirement of resuturing of episiotomy or evacuation of hematoma
时间窗: up to 6 weeks following delivery
Any additional surgical intervention required relating to the episiotomy, as recorded in medical records
Blood transfusion requirement
时间窗: Up to 5 days following delivery
Any requirement for blood products following delivery as documented in the hospital discharge
Post-partum hemorrhage
时间窗: Up to 6 weeks following delivery
Early (\<24 hours) or later (24 hours to 6 weeks) hemorrhage following delivery requiring physician intervention as documented in medical records
Long-term symptoms related to episiotomy
时间窗: Up to 5 years following delivery
Any symptoms including perineal pain, dyspareunia, urine incontinence or fecal incontinence as reported by women using a numerical scale or dichotomic scale where appropriate
Perineal tears in subsequent deliveries
时间窗: Up to 5 years following delivery
As recorded in hospital records
Surgical correction of episiotomy
时间窗: Up to 5 years following delivery
Any additional surgical procedures required for correction of episiotomy related symptoms as recorded in medical records
Extended laceration of the episiotomy
时间窗: Up to 1 hour following the episiotomy
Additional perineal tears originating from the original episiotomy, as described in the birth chart
Episiotomy site infection
时间窗: Up to 6 weeks following delivery
any documented infection of the episiotomy site treated in ambulatory or hospital setting, as recorded in medical records
次要结局
未报告次要终点
研究者
Sharon Davidesko MD
Principal Investigator
Soroka University Medical Center