Gum Chewing And Bowel Motility in Patients Undergoing Cesarean Section. Kasr el Ainy Experience (RCT)

January 29, 2016 updated by: Mohamed El-Sharkawy, Kasr El Aini Hospital

Gum Chewing And Bowel Motility in Patients Undergoing Cesarean Section. Kasr el Ainy Experience.A Randomized Controlled Trial

The aim of the present study was to evaluate the effect of chewing gum on the recovery of bowel function after cesarean section in women.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study Will Be conducted on 162 Patients Undergoing caesarean section in The Obstetrics & Gynecology Department "kasr el ainy teaching hospital".

Methods:

Women Were Randomized into Two Groups: Group A (81 Women) Who Received One Stick of Sugarless Gum (Samara for food & Chocolates Product Company)"S.A.E." , for 15 Minutes Every 2 hours After Surgery Tell Defecation , Group B (81 Women) had Traditional Management (Oral Intake of Clear Fluid Allowed After Passage of Flatus and Regular Diet With The Passage of Bowel Movement.

Each Women in Both Groups Was Examined Abdominal Using A Stethoscope Detect The Intestinal Movement Every 4 Hours And Asked to Report Immediately The Time of Either Passing Flatus or stool .

Study Type

Interventional

Enrollment (Anticipated)

162

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Mohamed Abdel Aziz El Sharkawy
      • Cairo, 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:

  1. Age between 18 - 35 Years.
  2. Spinal Anesthesia.
  3. Pfannenstiel incision.

Exclusion Criteria:

  1. History of Drug Consumption Especially Opioids.
  2. Water and Electrolyte Disturbances.
  3. Pancreatitis.
  4. Peritonitis.
  5. History of Abdominal Surgery except Cesarean Section.
  6. No Willingness to Cooperative.
  7. Intra and Sever Post-Operative Complications.
  8. Inability to Chew Gum with Drawl.
  9. Diabetes.
  10. Pre-eclampsia
  11. Prolonged Rupture of Membranes.
  12. Hypothyroidism.
  13. Muscular and Neurological Disorders.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: gum chewing group.
Group A (81 Women) Who Received One Stick of Sugarless Gum (Samara for food & Chocolates Product Company)"S.A.E." , for 15 Minutes Every 2 hours After Surgery Tell Defecation
Biological: sugarless gum
One Stick of Sugarless Gum (Samara for food & Chocolates Product Company)"S.A.E." , for 15 Minutes Every 2 hours After Surgery Tell Defecation
Other Names:
  • Samara Gum
Placebo Comparator: Placebo group
Group B (81 Women) had Traditional Management (Oral Intake of Clear Fluid Allowed After Passage of Flatus and Regular Diet With The Passage of Bowel Movement.
Other: traditional management
Traditional Management (Oral Intake of Clear Fluid Allowed After Passage of Flatus and Regular Diet With The Passage of Bowel Movement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the first audible bowel sound in hours
Time Frame: 4 months
The First Bowel Sounds (Hours) The First Passage of Flatus (Hours) The First Defection (Hours) The First Bowel Sounds (Hours) The First Passage of Flatus (Hours) The First Defection (Hours) the first auscultation of regular bowel sounds in hours
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient satisfaction
Time Frame: 4 months
Change From Baseline in Pain on the 11 point Short Pain Scale (SPS-11)
4 months

Collaborators and Investigators

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

Sponsor

Kasr El Aini Hospital

Investigators

  • Study Chair: Kasr El Ainy, kasr el ainy street,cairo,egypt

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

August 1, 2015

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

August 21, 2015

First Submitted That Met QC Criteria

August 26, 2015

First Posted (Estimate)

August 27, 2015

Study Record Updates

Last Update Posted (Estimate)

February 1, 2016

Last Update Submitted That Met QC Criteria

January 29, 2016

Last Verified

August 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • KasrELAini hospital

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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