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

Gum Chewing Clinical Trial

— RCT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02533830
• Other study ID #: KasrELAini hospital
• Status: Recruiting
• Phase: Phase 4
• First received: August 21, 2015
• Last updated: January 29, 2016
• Start date: August 2015
• Est. completion date: July 2016

Study information

• Verified date: August 2015
• Source: Kasr El Aini Hospital
• Contact: Mohamed Ab El Sharkawy
• Phone: 00201221731328
• Email: kingdoc82[@]outlook.com
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bowel Function
• Gum Chewing

Intervention

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:
• traditional management
Traditional Management (Oral Intake of Clear Fluid Allowed After Passage of Flatus and Regular Diet With The Passage of Bowel Movement.

Locations

Country	Name	City	State
Egypt	Mohamed Abdel Aziz El Sharkawy	Cairo
Egypt	Mohqmed El Sharkawy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the first audible bowel sound in hours	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	Yes
Secondary	patient satisfaction	Change From Baseline in Pain on the 11 point Short Pain Scale (SPS-11)	4 months	Yes