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临床试验/NCT02386748
NCT02386748已完成不适用

Chewing Gums to Stimulate Intestinal Motility After Cesarean Section: A Randomized Controlled Trial

Ain Shams University2 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
450
试验地点
2
主要终点
Passage of stools

研究概览

简要总结

The study purpose is to evaluate the efficacy and safety of postoperative gum chewing on the recovery of intestinal movement after cesarean section.

All women undergoing elective cesarean section in King Faisal military hospital will be candidate for this trial after full explanation of the trial and informed consent to be taken from the women. Exclusion criteria will include emergency cesarean section, multifetal pregnancy, polyhydramnios, medical disorders with pregnancy, abnormal placentation (previa and/or accreta), past history of bowel injury or operation, any complications that will increase operative duration such as uterine artery injury or uterine extension.

450 consented women for being enrolled in this clinical trial and candidates for elective cesarean section will be divided into 3 groups:

  • Group A, 150 women will receive sugarless gum after their operating room discharge by 2 hours for at least half an hour at two hours interval.
  • Group B, 150 women will receive the traditional management of starting oral fluids after operating room discharge by 6 hours and hearing intestinal sounds on second day before initiating full regular diet.
  • Group C, 150 women as control group, they will not receive neither gum nor oral fluids. They will be in intravenous fluid.

All demographic data of these women, indication of operation, operation time, type of anesthesia and pathway during hospital stay will be recovered and compared between 3 groups.

详细描述

Introduction; Cesarean section is the most common surgery among women which is associated with postoperative central nervous system (CNS) changes, leading to decreased bowel movements. Postoperative ileus is defined as transient cessation of coordinated bowel motility after surgical intervention. It Is one of the major problems of post-abdominal surgery which delays hospital discharge, causes abdominal pain, abdominal distension, inability to start oral feeding, breastfeeding, and eventually increases the cost of hospital care. Historically, professionals of gynecology and obstetrics waited until gut function returns allowing oral or entered feeding, characterized by symptoms such as bowel sounds, first flatus or stool, and feeling of hunger. Chewing gum can stimulate the stomach, enhances gastric secretion, increases peristaltic bowel movements and finally hastens recovery from ileus. It has also been recently considered by researchers as a strategy toward ileus reduction. It seems that a necessity is felt for more investigation on such a least-expensive physiological method in stimulating the return of bowel function.

Study purpose; To evaluate the efficacy and safety of postoperative gum chewing on the recovery of intestinal movement after cesarean section.

Intervention:

450 consented women for being enrolled in this clinical trial and candidates for elective cesarean section will be divided into 3 groups:

  • Group A, 150 women will receive sugarless gum after their operating room discharge by 2 hours for at least half an hour at two hours interval.
  • Group B, 150 women will receive the traditional management of starting oral fluids after operating room discharge by 6 hours and hearing intestinal sounds on second day before initiating full regular diet.
  • Group C, 150 women as control group, they will not receive neither gum nor oral fluids. They will be in intravenous fluid.

研究设计

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

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • All women undergoing elective cesarean section in King Faisal military hospital will be candidate for this trial after full explanation of the trial and informed consent to be taken from the women.

排除标准

  • Emergency cesarean section.
  • Multiple pregnancies.
  • Polyhydramnios.
  • Medical disorder as hypertension or diabetes mellitus.
  • Abnormal placentation ,placenta previa ,accreta.
  • Past history of bowel injury or operation.
  • Any complications that will increase operative duration such as uterine artery injury or uterine extension.

结局指标

主要结局

Passage of stools

时间窗: 72 hours

次要结局

  • Passage of flatus(72 hours)

研究者

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

Mohamed Ellaithy

Associate professor

Ain Shams University

研究点 (2)

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