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临床试验/NCT03377894
NCT03377894Unknown2 期

Comparison Between Blunt Versus Sharp Expansion of Uterine Incision at Lower Segment Cesarean Section as Regards the Intra-operative Blood Loss & Postoperative Pain

Kasr El Aini Hospital2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年12月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
发起方
入组人数
200
试验地点
2
主要终点
The operative time is recorded in minutes

研究概览

简要总结

comparison between blunt versus sharp expansion of uterine incision at lower segment cesarean section in primigravida as regards the intra-operative blood loss & postoperative pain

详细描述

the study includes 200 pregnant women, primigravidas, at term who underwent elective transverse lower segment Cesarean section for the first time among the age group of 20 - 37 years with a singleton pregnancy.

The patients are divided randomly into two groups as follows:

  • Group (A): undergoing blunt uterine incision expansion
  • Group (B): undergoing sharp uterine incision expansion

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 37 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • singleton pregnancy.

排除标准

  • previous PID
  • any medical or psychiatric
  • patients with BMI ≥ 40
  • multigravidas
  • chronic analgesia use,
  • allergy to analgesics,
  • multiple pregnancies are also excluded

研究组 & 干预措施

• Group (A) blunt incision

Active Comparator

100 primigravidas at term who underwent elective transverse lower segment Cesarean section for the first time among the age group of 20 - 37 years with a singleton pregnancy.

undergoing blunt uterine incision expansion

干预措施: blunt uterine incision expansion (Procedure)

• Group (B) sharp incision

Active Comparator

100 primigravidas, at term who underwent elective transverse lower segment Cesarean section for the first time among the age group of 20 - 37 years with a singleton pregnancy undergoing sharp uterine incision expansion

干预措施: sharp uterine incision expansion (Procedure)

结局指标

主要结局

The operative time is recorded in minutes

时间窗: from skin incision till skin closure

The operative time is recorded in minutes

intraoperative bleeding

时间窗: from skin incision till skin closure

The intra-operative blood loss is evaluated by towels as follows: The surgical towels will be weighed (gm) before and after the operation, and the difference in weight between dry and soaked towels will be calculated. Blood loss during the operation will be calculated by adding the volume of the contents of the suction bottle (ml) to the difference in weight of towels (gm) (weight of soaked towels - weight of dry towels).

post operative pain

时间窗: one hour after cs

Post-operative pain is analyzed by using 4 point verbal rating scale (VRS) which consists of a list of adjectives describing different levels of pain intensity i.e (no pain =1, mild pain = 2, moderate pain = 3, severe pain = 4)

次要结局

未报告次要终点

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

sarah mohamed hassan

lecturer of obstetrics and gynecology

Kasr El Aini Hospital

研究点 (2)

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