Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Gum chewing and return of bowel motility after elective caesarean section: a randomised controlled single-centre trial
Acronym
Study hypothesis
Post-operative gum chewing enhances the return of bowel motility after elective caesarean section (CS).
Ethics approval
This study was approved by the Ethics and Research Committee of Obstetrics and Gynaecology Department, Faculty of Medicine, Ain Shams University in June 2006.
Study design
Randomised controlled single-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Resumption of bowel motility after caesarean section (CS)
Intervention
This trial took place at Ain Shams University Maternity Hospital. The participants will be randomly allocated to the following two groups:
1. Group I (study group): 93 patients will receive one stick of sugarless gum (Samarah Foods, Egypt) for 15 minutes starting two hours after end of CS and every two hours thereafter (during waking time, stopped during overnight sleep) until the passage of flatus or bowel movement
2. Group II (control group): 107 patients will receive traditional post-operative management, with oral intake of clear fluids and soft foods allowed after the passage of flatus and regular diet after bowel movement
For both groups, no subject will be given oral or rectal bowel stimulants after CS. The same post-operative rehabilitation programme for ambulation, excluding gum chewing, will be used for the control group. Auscultation for intestinal sounds will be performed at 4 to 6 hour intervals. The patients will be allowed to sip small amounts of water only 12 hours post-operatively. The oral intake of clear fluids and soft foods will be allowed when normal bowel sounds are detected and flatus has passed with advancement to a regular diet after passage of first bowel motion.
Eligible criteria for hospital discharge are stable vital signs with no febrile morbidity for at least 24 hours, ability to ambulate and urinate without assistance, passage of a bowel motion, ability to tolerate solid food without emesis and absence of unresolved other post-operative complications. For analgesia, two intramuscular doses of 75 mg diclofenac sodium (Voltaren®, Novartis Pharma, Egypt), a nonsteroidal anti-inflammatory medication, will be routinely given at 2 and 12 hours post-operatively. The need for additional use of narcotics (pethidine, 1 mg/kg) will be recorded.
The participants are to be followed-up by the study team until discharge from hospital. However, any side-effects, complication and unexpected events presented by the participants during the postpartum period (until 5-6 weeks after delivery) are also to be recorded.
Intervention type
Drug
Phase
Phase III
Drug names
Chewing gum
Primary outcome measures
With the time of end of surgery designated as zero hour:
1. The time interval to first hearing of normal intestinal sounds
2. The time interval to the first passage of flatus
3. The time interval to the first bowel movement
4. The time interval to the discharge from the hospital
Secondary outcome measures
1. In Group I only: post-operative tolerance of gum chewing
2. In both groups: post-operative complications, including:
2.1. Febrile morbidity (temperature greater than 38º C on two occasions 6 hours apart)
2.2. Re-operation
2.3. Blood transfusion
2.4. Post-operative ileus. The occurrence of mild ileus symptoms (vomiting or abdominal distension felt by the patient and seen on examination) or post-operative paralytic ileus, defined as a group of manifestations persisting longer than 24 hours or requiring nasogastric tube placement. These manifestations include absent or hypoactive bowel sounds, non-passage of flatus or bowel movement, abdominal distension, more than three episodes of vomiting, with or without generalised crampy abdominal pain.
2.5. Hospital readmission
Overall trial start date
01/07/2006
Overall trial end date
31/01/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Pregnant women set for planned elective CS under general anaesthesia
2. No age limits
3. Written and signed informed consent by the patient to participate in the study
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
200
Participant exclusion criteria
1. Operation to be done not in the morning session
2. Patients undergoing caesarean hysterectomy or other extensive intra-abdominal surgery as a result of operative complication
Recruitment start date
01/07/2006
Recruitment end date
31/01/2007
Locations
Countries of recruitment
Egypt
Trial participating centre
Ain Shams University Maternity Hospital
Cairo
11566
Egypt
Sponsor information
Organisation
Ain Shams University Maternity Hospital (Egypt)
Sponsor details
c/o Prof Karim H I Abd-El-Maeboud
Abbassia
Cairo
11566
Egypt
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Ain Shams University Maternity Hospital (Egypt)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary