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

Phase 4

• Conditions: Intestinal Recovery After Cesarean Section
• Interventions: Other: gums; Drug: picolax drops; Drug: normal saline

• Registration Number: NCT02765971
• Lead Sponsor: Ahmed M Maged, MD

Brief Summary

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 .

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 Timeline

• Study First Submitted: 2016-04-30
• Study Start: 2016-05
• Study First Submitted QC: 2016-05-06
• Study First Posted: 2016-05-09
• Status Verified: 2019-09
• Primary Completion: 2019-09
• Last Update Submitted: 2019-09-20
• Last Update Posted: 2019-09-23
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 540

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
chewing gum group	gums	180 women will receive sugarless gum after their operating room discharge by 3 hours for at least half an hour at two hours interval
laxatives group	picolax drops	180 women will receive laxatives after their operating room discharge by 3 hours
control	normal saline	they will not receive neither gum nor oral fluids. They will be on intravenous fluid. starting oral fluids after hearing intestinal sounds

Primary Outcome Measures

Name	Time	Method
appearance of intestinal sounds postoperative evaluated by stethoscope	4-6 hours after CS

Trial Locations

Locations (1)

Kasr Alainy medical school; 🇪🇬 Cairo, Egypt