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Does gum chewing enhance return of bowel movement after caesarean section?
ISRCTN ISRCTN86084115
DOI 10.1186/ISRCTN86084115
ClinicalTrials.gov identifier
EudraCT number
Public title Does gum chewing enhance return of bowel movement after caesarean section?
Scientific title Gum chewing and return of bowel motility after elective caesarean section: a randomised controlled single-centre trial
Acronym N/A
Serial number at source N/A
Study hypothesis Post-operative gum chewing enhances the return of bowel motility after elective caesarean section (CS).
Lay summary
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
Countries of recruitment Egypt
Disease/condition/study domain Resumption of bowel motility after caesarean section (CS)
Participants - 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
Participants - 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
Anticipated start date 01/07/2006
Anticipated end date 31/01/2007
Status of trial Completed
Patient information material
Target number of participants 200
Interventions 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.
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
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
Sources of funding Ain Shams University Maternity Hospital (Egypt)
Trial website
Publications
Contact name Prof  Karim H I  Abd-El-Maeboud
  Address Ain Shams University Maternity Hospital
Abbassia
  City/town Cairo
  Zip/Postcode 11566
  Country Egypt
Sponsor Ain Shams University Maternity Hospital (Egypt)
  Address c/o Prof Karim H I Abd-El-Maeboud
Abbassia
  City/town Cairo
  Zip/Postcode 11566
  Country Egypt
  Sponsor website: http://med.shams.edu.eg/index.php
Date applied 21/10/2008
Last edited 03/11/2008
Date ISRCTN assigned 30/10/2008
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