The Efficacy of Chewing Gums Versus Laxative in Early Return of Bowel Function After CS

September 20, 2019 updated by: Ahmed M Maged, MD

The Efficacy of Chewing Gums Versus Laxatives in Early Return of Bowel Function After Cesarean Section

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

  • Group A, 180 women will receive sugarless gum after their operating room discharge by 3 hours for at least half an hour at two hours interval.
  • Group B, 180 women will receive laxatives after their operating room discharge by 3 hours.
  • Group C, 180 women as control group, they will not receive neither gum nor oral fluids. They will be on intravenous fluid. starting oral fluids after hearing intestinal sounds .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

  • Group A, 180 women will receive sugarless gum after their operating room discharge by 3 hours for at least half an hour at two hours interval.
  • Group B, 180 women will receive laxatives after their operating room discharge by 3 hours.

Group C, 180 women as control group, they will not receive neither gum nor oral fluids. They will be on intravenous fluid. starting oral fluids after hearing intestinal sounds .

Study Type

Interventional

Enrollment (Anticipated)

540

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 Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 12151
        • Recruiting
        • Kasr Alainy medical school

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 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • all women undergoing elective cesarean section in Kasr Al AI Aini hospital will be candidate for this trial after full explanation of the trial and informed consent to be taken from the women.

Exclusion Criteria:

  • cesarean hysterectomy,
  • surgical management of severe postpartum hemorrhage
  • previous bowel surgery
  • women with history of drug consumption,especially opioids
  • water and electrolyte disturbances
  • pancreatitis or peritonitis
  • inability to chew gum
  • diabetes, pregnancies accompanied by coagulopathy like pre-eclampsia, hypothyroidism, muscular and neurological disorders
  • postoperative admission to intensive care unit
  • history of abdominal surgery except cesarean section
  • history of postoperative ileus
  • patients with drains

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: chewing gum group
180 women will receive sugarless gum after their operating room discharge by 3 hours for at least half an hour at two hours interval
Other: gums
Group A, 180 women will receive sugarless gum after their operating room discharge by 3 hours for at least half an hour at two hours interval.
Other Names:
  • non sweet gums
Active Comparator: laxatives group
180 women will receive laxatives after their operating room discharge by 3 hours
Drug: picolax drops
Group B, 180 women will receive laxatives after their operating room discharge by 3 hours.
Placebo Comparator: control
they will not receive neither gum nor oral fluids. They will be on intravenous fluid. starting oral fluids after hearing intestinal sounds
Drug: normal saline
Group C received 500 cc of normal saline, Intravenous fluid
Other Names:
  • .9%saline infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
appearance of intestinal sounds postoperative evaluated by stethoscope
Time Frame: 4-6 hours after CS
4-6 hours after CS

Collaborators and Investigators

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

Sponsor

Ahmed M Maged, MD

Investigators

  • Principal Investigator: Ahmed Maged, 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 (Actual)

May 1, 2016

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

April 30, 2016

First Submitted That Met QC Criteria

May 6, 2016

First Posted (Estimate)

May 9, 2016

Study Record Updates

Last Update Posted (Actual)

September 23, 2019

Last Update Submitted That Met QC Criteria

September 20, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 143

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Intestinal Recovery After Cesarean Section

Clinical Trials on gums

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe