We study the effect of gum chewing on the return of bowel movements after elective cesarean section. In a randomized clinical trial, 100 patients (from Rohani hospital, Bobol, Iran), who are candidates for cesarean section, are randomly and equally allocated to chewing gum or control groups after the operation. The patients in the gum-chewing group chew gum 3 times daily, each time for 15 minutes as soon as they become conscious till the time they pass flatus or defecate. Control group only receive after operation care. The first time to flatus passage, defecation, hearing of bowel sound and sensation of bowel movement are compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201008093902N2
Registration date:2011-03-06, 1389/12/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-03-06, 1389/12/15
Registrant information
Name
Farideh Mohsenzadeh
Name of organization / entity
Babol university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1229 8582
Email address
f.mohsenzadeh@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol university of medical sciences
Expected recruitment start date
2010-06-06, 1389/03/16
Expected recruitment end date
2011-03-20, 1389/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of gum chewing on the return of bowel function in cesarean–delivery patients.
Public title
The effect of gum chewing on the return of bowel function in cesarean–delivery patients.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: consent, uncomplicated term singleton pregnancies undergoing a planned caesarean section performed under spinal anaesthesia and by an gynecologist, transverse (horizontal) incision, at least NPO for 8 hours before surgery, receiving maximum four doses of antibiotic prophylaxis. Exclusion criteria: History of abdominal surgery , preeclampsia, diabetes, heart disease, , postoperative complications such as uterine atonia, intra operative complications such as severe adhesions and blood transfusion during surgery, surgery lasted more than 60 minutes, receiving magnesium sulfate, history of malignancy, obstructive or inflammatory bowel diseases and injuries, excessive bowel manipulation, inability to chew gum.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol university of medical sciences
Street address
Babol university of medical sciences
City
Babol
Postal code
4713838149
Approval date
2010-04-14, 1389/01/25
Ethics committee reference number
30/111
Health conditions studied
1
Description of health condition studied
Ileus
ICD-10 code
K56.0
ICD-10 code description
Paralytic ileus
Primary outcomes
1
Description
Gas passing
Timepoint
Every hour
Method of measurement
Asking from patients
2
Description
Hearing bowel sound
Timepoint
Every hour
Method of measurement
stethoscope
3
Description
Flatus passing
Timepoint
Every hour
Method of measurement
Asking from patients
4
Description
Sensation of bowel movement
Timepoint
Every hour
Method of measurement
Asking from patients
5
Description
Sensation of hunger
Timepoint
Every hour
Method of measurement
Asking from patients
Secondary outcomes
empty
Intervention groups
1
Description
Group A chewed sugarless gum for 15 minutes 3 times per day as soon as they recovered from anesthesia till they passed flatus or defecated
Category
Prevention
2
Description
Control group: Routine post-op care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol university of medical sciences (Rohani hospital)
Full name of responsible person
Farideh mohsenzadeh
Street address
Babol university of medical sciences
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol university of medical sciences
Full name of responsible person
Amrollah Mostafazadeh
Street address
Babol university of medical sciences
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol university of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Babol university of medical sciences
Full name of responsible person
Shanaz Barat
Position
Obstetric & Gynecologist/faculty member
Other areas of specialty/work
Street address
Babol university of medical sciences
City
Babol
Postal code
4713838149
Phone
+98 11 1219 9595
Fax
Email
shanaz_barat200@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol university of medical sciences
Full name of responsible person
Farideh Mohsenzadeh
Position
Midwifery msc/faculty member
Other areas of specialty/work
Street address
Babol university of medical sciences midwifery group
City
Babol
Postal code
4713838149
Phone
+98 11 1219 9597
Fax
+98 11 1219 3696
Email
mohsenzadh2008@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol university of medical sciences
Full name of responsible person
Farideh Mohsendeh
Position
Midwifery msc/faculty member
Other areas of specialty/work
Street address
Babol university of medical sciences
City
Babol
Postal code
4713838149
Phone
+98 11 1219 9597
Fax
+98 11 1219 3696
Email
mohsenzadh2008@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)