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临床试验/NCT05247073
NCT05247073Unknown不适用

A Randomized Controlled Trial to Evaluate the Mostafa Maged Four-stitch Technique in Comparison With the Regular Method in Closure of the Episiotomy During Vaginal Delivery

Fayoum University0 个研究点目标入组 50 人开始时间: 2022年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
No infection at the episiotomy

研究概览

简要总结

Most primigravida is confronted with episiotomy during childbirth to prevent the perineal and vaginal lacerations which could be performed at birth. There are many types of episiotomy which are median, mediolateral, and J-shaped episiotomy.

Prevention of the formation of the dead space during the repair of episiotomy so avoiding hematoma formation in the episiotomy area after child-birth.

The Mostafa Maged four-stitch technique uses absorbable vicryl threads with round needles 75 mm.

详细描述

Methodology: This technique will be applied to all women with episiotomy at the time of delivery or having tears in the perineum or the vagina. The technique uses absorbable vicryl threads with round needles 75 mm long. The technique includes the vaginal epithelium and the deep muscle layer together continuously at the same sutures. Assessment of the perineal area in the next twenty-four hours till discharge looking for (edema - hematoma - septic wound - continence - ecchymosis - dyspareunia).

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)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Primigravida patients having episiotomies or tears in the vagina
  • Age between 18 to 40 years old

排除标准

  • Morbidly obese patients
  • Chronic diseases such as renal diseases

结局指标

主要结局

No infection at the episiotomy

时间窗: 4 weeks after delivery

Redness,hotness and bad odour of vaginal discharge

No edema at the site of episiotomy

时间窗: 4 weeks after delivery

Swelling or ecchymosis and edema at the edges of episiotomy

Heamostasis of the episiotomy

时间窗: 4 weeks after delivery

Bleeding from the epistiomy or heamatoma at the epistomy

次要结局

  • Sexual dysfunction (pain during sexual intercourse)(4 weeks after delivery)
  • Anorectal dysfunction(4 weeks after delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

rehab abdelhamid aboshama

lecturer of obstetrics and gynecology Faculty of medicine

Fayoum University

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