Chewing Gums to Stimulate Intestinal Motility After Cesarean Section

March 9, 2017 updated by: Mohamed Ellaithy, Ain Shams University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Asir
      • Khamis Mushait, Asir, Saudi Arabia, 101
        • Postpartum ward of Armed Forces Hospital, Southern Region.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chewing gum
Chewing sugarless gum
Dietary supplement: Chewing gum
Chewing sugarless gum after the discharge from the operating room by two hours for at least half an hour at two hours intervals.
Other: Intravenous fluids
Women in this group will not receive neither gum nor oral fluids, they will be on intravenous fluids (lactated ringer solution).
Active Comparator: Oral fluids
Clear oral fluids
Other: Intravenous fluids
Women in this group will not receive neither gum nor oral fluids, they will be on intravenous fluids (lactated ringer solution).
Dietary supplement: Oral fluids
Starting clear oral fluids after operating room discharge by six hours, then hearing intestinal sounds on second day before initiating full regular diet.
Other: Intravenous fluids
No chewing gum No oral fluids Only intravenous fluids (Lactated Ringer's solution)
Other: Intravenous fluids
Women in this group will not receive neither gum nor oral fluids, they will be on intravenous fluids (lactated ringer solution).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Passage of stools
Time Frame: 72 hours
72 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Passage of flatus
Time Frame: 72 hours
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Collaborators

Armed Forces Hospitals, Southern Region, Saudi Arabia

Investigators

  • Study Chair: Mohamed I Ellaithy, MD, Armed Forces Hospital, Southern Region
  • Study Director: Ahmed Traigey, MD, Armed Forces Hospital, Southern Region

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

March 5, 2015

First Submitted That Met QC Criteria

March 5, 2015

First Posted (Estimate)

March 12, 2015

Study Record Updates

Last Update Posted (Actual)

March 10, 2017

Last Update Submitted That Met QC Criteria

March 9, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AFHSR 1-3-2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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