the Role of Gum Chewing in Regaining Bowel Motility in Patients Undergoing Cesarean Section (RCT)

September 9, 2018 updated by: Mona M Shaban, Cairo University

The Role of Sugarless Gum Chewing in Regaining Bowel Motility in Patients Undergoing Cesarean Section

Aim:to evaluate the efficacy of postoperative gum chewing on the recovery of bowel motility after cesarean section.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

this study will be conducted on 162 patients undergoing cesarean section in obstetrics and gynecology department at Kasr el Ainy Hospital,Kairo university.

Study Type

Interventional

Enrollment (Actual)

162

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

  • Egypt
      • Cairo, Egypt
        • Cairo University Hospital,obstetrics and gynecology departement, Egypt
      • Cairo, Egypt
        • Woman's Health University Hospital, Egypt

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

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age 18-35

    --Spinal anesthesia

  • Pfannensteil incision

Exclusion Criteria:

  • History of drug consumption especially opioids
  • water and electrolyte disturbance
  • History of abdominal surgery except cesarean section
  • Intra and severe post operative complications
  • diabetes
  • Pre-eclampsia
  • Hypothyroidism
  • Muscular and neurological disorder
  • Inability to chew gums

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: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 81 patients,group 1
81 women will receive 1 stick of sugarless gum for 15 minutes every 2 hours after surgery .
Drug: sugarless gum
81 patients will receive 1 stick of sugarless gum(Samara gum) for 15 minutes every 2 hours
Other Names:
  • Samara Gum
NO_INTERVENTION: 81 patients,group 2
81 patients will have traditional management(oral intake of clear fluids after hearing of first intestinal sounds or passage of flatus and regular diet after passage of stool)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
first bowel sound in hours
Time Frame: 4-6 hours
4-6 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
first passage of flatus in hours,the first defecation in hours
Time Frame: 4-6 hours
4-6 hours

Collaborators and Investigators

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

Sponsor

Cairo University

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

June 1, 2015

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

July 1, 2016

Study Registration Dates

First Submitted

May 24, 2018

First Submitted That Met QC Criteria

June 5, 2018

First Posted (ACTUAL)

June 6, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 11, 2018

Last Update Submitted That Met QC Criteria

September 9, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • Woman Health University Egypt

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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