This study aimed to compare early liquids and gum chewing on the return of bowel movements after elective cesarean section performed in Shahrekord Hajar hospital. In a randomized clinical trial, 180 patients, who were candidates for cesarean section, were randomly and equally (n = 60) allocated to one of following groups: chewing gum, early feeding or control group after the operation. The patients in the gum-chewing group chewed gum 4 times daily each time for 15 minutes as soon as they become conscious till the time they passed flatus or defecated. Early feeding group fed with clear liquids, regardless of bowel sound within 4 hours after surgery and Soft regime began after listening of intestinal Sound. In the control group, liquids regime was started and gradually converted to regular diet after listening of intestinal Sound. The first time to flatus passage, defecation, hearing of bowel sound, and sensation of bowel movement in the three groups were compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902222265N1
Registration date:2010-07-03, 1389/04/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-07-03, 1389/04/12
Registrant information
Name
Faranak Safdari Decheshmeh
Name of organization / entity
Shahrekord Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 5648
Email address
safdari@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research, Shahrekord University of Medical Sciences
Expected recruitment start date
2008-04-08, 1387/01/20
Expected recruitment end date
2009-10-08, 1388/07/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of early initiation of oral feeding and Gum Chewing on the Return of Bowel Function in elective Cesarean-Delivery
Public title
Comparing early initiation of oral feeding and Gum Chewing on the Return of Bowel Function in elective Cesarean-Delivery Patients in primiparous women, Hajar hospitral, Shahrekord, 2007
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Uncomplicated term singleton pregnancies undergoing a planned caesarean section performed under regional anaesthesia and by an gynecologist, transverse (horizontal) incision, At least NPO for 8 hour before surgery, Received the maximum four doses of antibiotic prophylaxis,
Exclusions criteria: History of abdominal surgery or cesarean section, preeclampsia, diabetes, heart disease, being at risk for incidence of aspiration or ileuses, postoperative complications such as uterine atonia, intra operative complications such as severe adhesions and blood transfusion during surgery, surgery lasted more than 90 minutes, discharged with personal willing despite physician’s decision, intolerance liquid diet, presence of nausea and vomiting, receiving magnesium sulfate, history of malignancy, obstructive or inflammatory bowel diseases and injuries, excessive bowel manipulation, inability to chew gum.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences, Rahmatie, Shahrekord
City
Shahrekord
Postal code
Approval date
2008-02-20, 1386/12/01
Ethics committee reference number
1-12-86
Health conditions studied
1
Description of health condition studied
ileus
ICD-10 code
k00, k93,
ICD-10 code description
Diseases of the digestive system, Paralytic ileus
Primary outcomes
1
Description
Flatus passing
Timepoint
Every hour
Method of measurement
Asking from patients
2
Description
Gas passing
Timepoint
Every hour
Method of measurement
Asking from patients
3
Description
Hearing bowel sound
Timepoint
Every hour
Method of measurement
Hearing of bowel sound by stetoscope
4
Description
Sensation of bowel movement
Timepoint
Every hour
Method of measurement
Asking from patients
Secondary outcomes
1
Description
NAUSEA
Timepoint
PER ONE HOUR
Method of measurement
QUESITION FROM PATIENT
2
Description
Vomiting
Timepoint
Every hour
Method of measurement
Asking from patients
Intervention groups
1
Description
Routine post-op care: in control group after the appearance of bowel sounds oral hydration started and then a gradual shift to the regular diet was adopted
Category
Treatment - Other
2
Description
patient in the gum chewing group chewed sugarless gum one stick 4 times per day as soon as they recovered from anesthesia till the time they passed flatus or defected.
Category
Treatment - Other
3
Description
Oral hydration started with sips of Juice or tea 4-h postsurgury irrespective of presence of bowel sounds. soft diet was started after bowel sounds was appeared
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar Hospital
Full name of responsible person
Street address
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of research, Shahrekord University of Medical Sciences
Full name of responsible person
Faranak Safdari Dehcheshmeh
Street address
Midwifery and Nursing Department, Shahrekord University of Medical Sciences, Rahmatie
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research, Shahrekord 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
Shahrekord University Of Medical Science
Full name of responsible person
Faranak Safdari Decheshmeh
Position
Master Of Midwifery,Mentor Faculty Memmber
Other areas of specialty/work
Street address
Midwifery and Nursing Department, Shahrekord University of Medical Sciences, Rahmatie
City
Shahrekord
Postal code
Phone
+98 38 1333 5648
Fax
Email
faranaksafdari@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University Of Medical Sciences
Full name of responsible person
Faranak Safdari Decheshmeh
Position
Master of Midwifery
Other areas of specialty/work
Street address
Midwifery and Nursing Department, Shahrekord University of Medical Sciences, Rahmatie
City
Shahrekord
Postal code
Phone
+98 38 1333 5648
Fax
Email
faranaksafdari@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Faranak Safdari Decheshmeh
Position
Master of Midwifery ,Mentor Faculty Memmber
Other areas of specialty/work
Street address
Midwifery and Nursing Department, Shahrekord University of Medical Sciences, Rahmatie
City
Shahrekord
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)