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临床试验/CTRI/2021/11/037716
CTRI/2021/11/037716尚未招募4 期

EPISCISSORS-60 VERSUS BUSCH EPISIOTOMY SCISSORS - A RANDOMISED CONTROLLED TRIAL COMPARING EPISIOTOMIES AND INCIDENCE OF OASIS

DRCHIPPY TESS MATHEW1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2021年1月11日最近更新:
适应症

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)

研究者

发起方
DRCHIPPY TESS MATHEW
申办方类型
Other [self]

研究点 (1)

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