Evaluating the effect of chewing gum on post cesarean section bloating is the purpose of this study. In this double blinded randomized clinical trial which will took place between April 2015 to June 2015 in Sabzevar Mobini Hospital, Sabzevar, Iran. Eighty pregnant women who undergo cesarean section (elective or urgent) will enrolled in this study and randomly divided into two groups (Case and Control group). One to 4 hours after the surgery, the patients are encouraged to chew gums each 6 hours four about 15 minutes. The control group will be monitored by usual surgery ward care. Study data will be gathered by observation and filling the questionnaire. Auscultation of intestinal sounds in both groups was documented every hour till complete return of bowel sounds. A researcher who is not aware of the study will performed the auscultation. Blinding performed for intravenous group and same as aid researcher to auscultation bowel sounds. Also, the time of first gas passage, defecation and sensation of bowel movements was documented.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015041221710N1
Registration date:2015-06-28, 1394/04/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-28, 1394/04/07
Registrant information
Name
Batool Kamalimanesh
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 930 250 8805
Email address
kamalimaneshb1@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Sabzevar University of Medical Sciences
Expected recruitment start date
2015-05-05, 1394/02/15
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of chewing gum on the bloating after of cesarean section
Public title
The effect of chewing gum on the bloating after of cesarean section
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Filling the informed contest formy; Being nullipara; Lack of previous abdominal surgery; Lack of preeclampsia, Diabetes and cardiovascular disease; Being able to chew gum; Skin pfannenstiel incision and uterine transverse incision; Using general anesthesia
Exclusion criteria: Patients who are at risk of aspiration and ileus (such as radiation history, anastomosis and patients who are over sedated); Patients who are not willing to continue the study; Surgical complication such as uterine atonia; Using intravenous antibiotics for more than four doses after surgery; Surgical complication at time of the surgery such as sever adhesions, blood transfusion, damaging the intestine or bladder; Patients who are discharged by their own decision; Surgery duration more than 90 minutes; Using magnesium sulfate (because of possible risk of nausea); History of any inflammatory or obstructive intestine disease; Intestine manipulation or damage
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Sabzevar University of Medical Sciences
Street address
Sabzevar to Shahrood road, Sabzevar, Iran.
City
Sabzevar
Postal code
Approval date
2015-04-13, 1394/01/24
Ethics committee reference number
IR.MEDSAB.REC.1394.5
Health conditions studied
1
Description of health condition studied
The bloating after of Cesarean
ICD-10 code
K91.9
ICD-10 code description
Postprocedural disorder of digestive system, unspecified
Primary outcomes
1
Description
Time of first auscultation of bowel sounds
Timepoint
Every one hour after hearing the first sound
Method of measurement
Second
2
Description
Time of sensation of first bowel movement
Timepoint
Every one hour till the sensation of the first bowel movement
Method of measurement
Second
3
Description
Time of the fisrt gas passage
Timepoint
Every one hour till the first gas passage
Method of measurement
Second
4
Description
Time of the first defication
Timepoint
Every one hour till the first defication
Method of measurement
Second
Secondary outcomes
1
Description
Duration of Hospital stay
Timepoint
Duration between surgery and discharge
Method of measurement
Day
2
Description
Pain
Timepoint
Every 6 hours
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Gum group, an oral chewing gum every 6 hours
Category
Treatment - Drugs
2
Description
No intervention
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sabzevar Shahidan Mobini Hospital
Full name of responsible person
Batool Kamalimanesh
Street address
City
Sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Sabzevar University of Medical sciences
Full name of responsible person
Mohammad zadeh Mohammad
Street address
Building No.2, Fifth km Sabzevar SHahrood Road, Student Research Department, Sabzevar University of Medical Sciences, Sabzevar, Iran
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Sabzevar University of Medical sciences