Gum Chewing And Bowel Motility in Patients Undergoing Cesarean Section. Kasr el Ainy Experience
RCT
1 other identifier
interventional
162
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2015
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 21, 2015
CompletedFirst Posted
Study publicly available on registry
August 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedFebruary 1, 2016
August 1, 2015
11 months
August 21, 2015
January 29, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
patient satisfaction
4 months
Study Arms (2)
gum chewing group.
ACTIVE COMPARATORGroup 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
Placebo group
PLACEBO COMPARATORGroup 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.
Interventions
One Stick of Sugarless Gum (Samara for food \& Chocolates Product Company)"S.A.E." , for 15 Minutes Every 2 hours After Surgery Tell Defecation
Traditional Management (Oral Intake of Clear Fluid Allowed After Passage of Flatus and Regular Diet With The Passage of Bowel Movement.
Eligibility Criteria
You may qualify if:
- Age between 18 - 35 Years.
- Spinal Anesthesia.
- Pfannenstiel incision.
You may not qualify if:
- History of Drug Consumption Especially Opioids.
- Water and Electrolyte Disturbances.
- Pancreatitis.
- Peritonitis.
- History of Abdominal Surgery except Cesarean Section.
- No Willingness to Cooperative.
- Intra and Sever Post-Operative Complications.
- Inability to Chew Gum with Drawl.
- Diabetes.
- Pre-eclampsia
- Prolonged Rupture of Membranes.
- Hypothyroidism.
- Muscular and Neurological Disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Mohamed Abdel Aziz El Sharkawy
Cairo, Egypt
Mohqmed El Sharkawy
Cairo, Egypt
Study Officials
- STUDY CHAIR
Kasr El Ainy
kasr el ainy street,cairo,egypt
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of obstetrics and gynecology
Study Record Dates
First Submitted
August 21, 2015
First Posted
August 27, 2015
Study Start
August 1, 2015
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
February 1, 2016
Record last verified: 2015-08