Chewing Gums to Stimulate Intestinal Motility After Cesarean Section
Condition: Postoperative Care
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      All demographic data of these women, indication of operation, operation time, type of
      anesthesia and pathway during hospital stay will be recovered and compare between 3 groups.

      Statistical Methods:

      Analysis of the data will be done by IBM computer using SPSS (statistical product and service
      solution version 18). Quantitative variables will be described as mean with SD and median
      with range while Qualitative variables will be described as numbers and percentage.
      Chi-square test will be used to compare qualitative variables between groups. Independent
      sample t-test will be used to compare the groups as regard quantitative variables in
      parametric data (SD < 50% mean). Comparison between non-parametric groups will be done by
      using Mann-Whitney test. P value < 0.05 will be significant.
    

Intervention name(s): Chewing gum; Oral fluids; Intravenous fluids
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Chewing sugarless gum after the discharge from the operating room by two hours for at least half an hour at two hours intervals.; Starting clear oral fluids after operating room discharge by six hours, then hearing intestinal sounds on second day before initiating full regular diet.; Women in this group will not receive neither gum nor oral fluids, they will be on intravenous fluids (lactated ringer solution).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Cesarean section; Chewing gums; Intestinal motility