Protocol summary

Summary
This study aims to evaluate the effects of gum chewing, as a kind of pseudo-nutrition, on enhancement of bowel movement and early recovery of post-cesarean ileus. A total of 144 females who undergo cesarean section in Ali Ibn Abitaleb Hospital and hold inclusion criteria will be selected. Those who have preeclampsia, diabetics, heart disease, risks of aspiration and ileus; lack of satisfaction to continue participation; complications after surgery such as atonic uterus; intravenous antibiotic therapy more than 4 doses; complications during surgery, for example to the bladder and bowel; adhesion; length of operation >90 min; use of MgSO4 after cesarean; and history of malignancy or inflammatory bowel disease will be excluded from the study. After caesarean section, the participants will be randomly allocated into intervention (gum chewing) and control (non-gum chewing) groups. Members of the intervention group will be asked, as soon as they are transferred to the ward, to chew one sugar-free gum four times a day (morning, afternoon, night and before sleep) each for 30 minutes until the first flatus. The controls will start their regimen with mild liquids after hearing the first bowel sound. The main variables in this study are the first defecation time, the time of first post-cesarean flatus, and the time of hearing the first bowel sound.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016112931168N1
Registration date: 2017-01-18, 1395/10/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-01-18, 1395/10/29
Registrant information
Name
Samira Hosseini
Name of organization / entity
Medical University of Zahedan
Country
Iran (Islamic Republic of)
Phone
+98 51 3729 7180
Email address
hosseini.samira61@gmail.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of chewing gum on intestinal function in patients after cesarean section
Public title
The effect of chewing gum on intestinal function in patients after cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: women who have undergone caesarean section; Exclusion Criteria: suffering from preeclampsia, diabetics, and heart disease; having risks of aspiration and ileus; lack of patient satisfaction to continue participation; complications after surgery such as atonic uterus; intravenous antibiotic therapy more than 4 doses; complications during surgery, for example to the bladder and bowel; adhesion; length of operation >90 min; use of MgSO4 after cesarean; and history of malignancy or inflammatory bowel disease
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 144
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
using table of random numbers for random selection

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Office complex of Zahedan Medical university, Khalij e Fars Blv., Dr.Hesabi Square
City
Zahedan
Postal code
9816743463
Approval date
2014-10-04, 1393/07/12
Ethics committee reference number
1573

Health conditions studied

1

Description of health condition studied
post surgery ileus
ICD-10 code
K56.0
ICD-10 code description
Paralysis of: bowel colon intestine

Primary outcomes

1

Description
the first time of deffication
Timepoint
per 2 hours after cesarean and intervention
Method of measurement
Observation

2

Description
hearing the first bowel sound
Timepoint
per 2 hours after cesarean and intervention
Method of measurement
Observation

3

Description
the first time of gas passing
Timepoint
per 2 hours after cesarean and intervention
Method of measurement
Observation

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Chewing one sugar-free gum as soon as transferring the patient to ward 4 times (morning, afternoon, evening and bed time)
Category
Prevention

2

Description
Control group: lack of gum chewing, start of diet after hearing the first bowel sound
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali ebne Abitaleb hospital
Full name of responsible person
Street address
Dr.Hesabi square, Khash road
City
Zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Zahedan University of Medical Sciences
Full name of responsible person
Houshang Rafigh Doust
Street address
Khalij fars blvd. ,Dr Hesabi square, Zahedan University of Medical Sciences
City
Zahedan
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 Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Samira Hosseini
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Khalij Fars blv., Dr Hesabi square, Zahedan University of Medical Sciences
City
Zahedan
Postal code
0098543416708
Phone
+98 543416708
Fax
hosseini.samira@gmail.com
Email
hosseini.samira61@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Samira Hosseini
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Ali ibn Abitaleb hospital, Dr.Hesabi square, Khash street
City
Zahedan
Postal code
Phone
+98 915 654 5727
Fax
Email
hosseini.samira61@gmail.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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