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临床试验/NCT04338737
NCT04338737Unknown不适用

A Randomized Controlled Study of Early Versus Delayed Oral Post Operative Feeding After Cesarean Section

Kasr El Aini Hospital0 个研究点目标入组 300 人开始时间: 2020年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
300
主要终点
maternal satisfaction from time of initiation of oral feeding after caesarean section.

研究概览

简要总结

3 different post ceseraen secton feeding regmen are compared

详细描述

300 women admitted to the labor and delivery unit in kasr Elainy teaching hospital, Following the decision to perform a cesarean section because of obstetric indications. The study involved only elective cesarean sections.

The 300 patients participated in this work and will be randomly and equally divided into three groups:

  1. Group A :

It consists of 100 patients that will be allocated for early post-operative oral feeding receiving water and clear fluid approximately 2 hours after surgery, followed by soft food and regular diet 4 hours later irrespective to intestinal sounds, flatus or stool. 2. Group B :

It consists of 100 patients that will be allocated for early Postoperative oral feeding receiving water and clear fluid approximately 2 hours after surgery till the return of intestinal sounds, then soft food and regular diet later on. 3. Group C :

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •Maternal age from 20 to
  • •Primigravida and previous 1 or two cesarean section.
  • •Elective cesarean section.
  • •Regional anaesthesia.
  • •Singleton pregnancy

排除标准

  • •Medical disorders as (sever preeclampsia, diabetes, liver or kidney diseases).
  • •Intraoperative intestinal injury.
  • •Previous major abdominal surgery except cesarean section.
  • •Obstructed labor with

研究组 & 干预措施

fluid and soft food

Active Comparator

It consists of 100 patients that will be allocated for early post-operative oral feeding receiving water and clear fluid approximately 2 hours after surgery, followed by soft food and regular diet 4 hours later irrespective to intestinal sounds, flatus or stool.

干预措施: timming of feeding (Other)

fluid only

Active Comparator

It consists of 100 patients that will be allocated for early Postoperative oral feeding receiving water and clear fluid approximately 2 hours after surgery till the return of intestinal sounds, then soft food and regular diet later on.

干预措施: timming of feeding (Other)

Npo

Active Comparator

It consists of 100 patients that will receive no oral feeding till passage of flatus instead 2 to 3 Litres of intravenous fluid will be used for feeding. Water and fluid will be then offered, followed by soft foods and then a regular diet.

干预措施: timming of feeding (Other)

结局指标

主要结局

maternal satisfaction from time of initiation of oral feeding after caesarean section.

时间窗: before discharge from hospital (range of 24 hours)

Assessment of patient satisfaction before discharge from hospital using visual analogue scale.

duration minutes till return of bowel sound

时间窗: time interval in minutes from the end of surgery till the return of intestinal sound

hearing of intestinal sound

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

assisstant professor of obstetrcs and gynecology

Kasr El Aini Hospital

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