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临床试验/CTRI/2024/03/064733
CTRI/2024/03/064733尚未招募1 期

Comparison of perineal tears with routine episiotomy versus no episiotomy among multiparous women with previous term vaginal delivery : A Randomized controlled trial .

Jawaharlal Institute of Postgraduate Medical Education and Research1 个研究点 分布在 1 个国家目标入组 364 人开始时间: 2024年4月1日最近更新:

试验速览

阶段
1 期
状态
尚未招募
入组人数
364
试验地点
1
主要终点
To compare the rates of composite perineal tears among routine and no episiotomy group at time of delivery .composite perineal tears include Vulvovaginal tears /extension of episiotomy,Occurrence of tears in perineum in the no episiotomy group that requires suturing ,Obstetric anal sphincter injuries(OASIs)

研究概览

简要总结

Episiotomy is a procedure  done during childbirth where a small cut is made in the area between the vagina and the anus (perineum) to help with the delivery. This was initially thought to prevent severe tearing of perineum . It can cause complications like pain, bleeding, and difficulties during future intimate activities. The use of this method has become restrictive these days.Rates of episiotomy differs among various institutes .This study is done to compare the outcomes of routinely doing episiotomy versus not doing it.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • 1.Pregnant women in active labour with previous one vaginal delivery.
  • 2.Singleton pregnancy 3.Vertex presentation 4.More than 37 weeks 5.Perineum more than 3.5 cm in first stage 6.Estimated Birth weight between 2.5 kg and 3.5kg.

排除标准

  • 1.Operative vaginal delivery 2.Previous complete perineal tear 3.Shoulder dystocia 4.Severe preeclampsia 5.Uncontrolled diabetes 6.Heart disease 7.Fetal distress in second stage needing to expedite delivery.

结局指标

主要结局

To compare the rates of composite perineal tears among routine and no episiotomy group at time of delivery .composite perineal tears include Vulvovaginal tears /extension of episiotomy,Occurrence of tears in perineum in the no episiotomy group that requires suturing ,Obstetric anal sphincter injuries(OASIs)

时间窗: To compare the rates of composite perineal tears among routine and no episiotomy groups at the time delivery.composite perineal tears include Vulvovaginal tears /extension of episiotomy,Occurrence of tears in perineum in the no episiotomy group that requires suturing ,Obstetric anal sphincter injuries(OASIs).

次要结局

  • To evaluate perineal pain on Visual Analogue Score at 24 hours after delivery(To evaluate perineal pain & other associated symptoms at 6 weeks after delivery.)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Rajeswari G

Jawaharlal institute of postgraduate and medical research

研究点 (1)

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