Does gum chewing enhance return of bowel movement after caesarean section?

ISRCTN	ISRCTN86084115
DOI	https://doi.org/10.1186/ISRCTN86084115
Protocol serial number	N/A
Sponsor	Ain Shams University Maternity Hospital (Egypt)
Funder	Ain Shams University Maternity Hospital (Egypt)

Submission date: 21/10/2008
Registration date: 30/10/2008
Last edited: 03/11/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Karim H I Abd-El-Maeboud
Scientific

Ain Shams University Maternity Hospital
Abbassia
Cairo
11566
Egypt

Study information

Primary study design	Interventional
Study design	Randomised controlled single-centre trial
Secondary study design	Randomised controlled trial
Scientific title	Gum chewing and return of bowel motility after elective caesarean section: a randomised controlled single-centre trial
Study objectives	Post-operative gum chewing enhances the return of bowel motility after elective caesarean section (CS).
Ethics approval(s)	This study was approved by the Ethics and Research Committee of Obstetrics and Gynaecology Department, Faculty of Medicine, Ain Shams University in June 2006.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Chewing gum
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/01/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	200
Key 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
Key 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
Date of first enrolment	01/07/2006
Date of final enrolment	31/01/2007

Locations

Countries of recruitment

Egypt

Study participating centre

Ain Shams University Maternity Hospital

Cairo
11566
Egypt

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan