EPISCISSORS-60 VERSUS BUSCH EPISIOTOMY SCISSORS - A RANDOMISED CONTROLLED TRIAL COMPARING EPISIOTOMIES AND INCIDENCE OF OASIS
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- -Incidence of OASIS also noted
研究概览
简要总结
Episiotomy is a routine procedure done during the second stage of labour, to reduce the incidence of perineal injuries. Episiotomy if given too medially or too laterally doesn’t serve the purpose and can increase the incidence of OASIS (Obstetric Anal Sphincter InjurieS).Episiotomy is most effective if the angle is 45 degree from the midline after suturing. To attain this angle the episiotomy scissors should cut at an angle of 60degree from the midline when the perineum is bulging during delivery.
AIMS AND OBJECTIVES-) To compare the episiotomies using Episcissors-60 and Busch episiotomy scissors (length, distance from anal sphincter and angle of episiotomy) 2) To compare the incidence of OASIS with Episcissors-60 and Busch episiotomy scissors
Study designPatients are randomised into Busch group and Episcissors-60 group using the randomisation table. Episiotomy is given at crowning of head .The episiotomy is measured in the postnatal period for length, angle from midline and distance from anal sphincter. Any incidence of OASIS is noted.
**Study population:**It comprises of 200 patients who were given a mediolateral episiotomy using Episcissors-60 at the crowning of the foetal head (group 1). Another group of 200 patients who were given a mediolateral episiotomy using Busch episiotomy scissorsat the crowning of the foetal head (group2).Randomisation is done using a randomisation table online.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- Female
入选标准
- •Primigravida Cephalic presentation Normal/instrumental vaginal delivery Â.
排除标准
- •Multigravida Any patient not willing to participate are exempted Previous caesarean delivery malpresentation.
结局指标
主要结局
-Incidence of OASIS also noted
时间窗: -The episiotomy is measured in the immediate postnatal period | at BASELINE for length, angle from midline and distance from anal sphincter | -Incidence of OASIS also noted
-The episiotomy is measured in the postnatal period (IMMEDIATELY AFTER SUTURING-within half an hour of delivery) for length, angle from midline and distance from anal sphincter
时间窗: -The episiotomy is measured in the immediate postnatal period | at BASELINE for length, angle from midline and distance from anal sphincter | -Incidence of OASIS also noted
次要结局
- Incidence of OASIS also noted(immediately after delivery within 10 minutes of placental delivery)
