Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Karim H I Abd-El-Maeboud

ORCID ID

Contact details

Ain Shams University Maternity Hospital
Abbassia
Cairo
11566
Egypt

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

http://med.shams.edu.eg/index.php

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

Publication citations

Editorial Notes