Protocol summary

Summary
This clinical trial evaluate the effect of chewing gum on the initiation of a bowel movement after cesarean section was performed. Inclusion criteria included uncomplicated and non-emergency cesarean section, and exclusion criteria are not satisfied on 92 new women at cesarean delivery was performed Bint Huda Bojnourd. Randomly divided into two groups, consumer groups Gum 46 = n 46 = n and control groups. Mothers receive the chewing of consciousness sugar free gum three times a day at 8, 14, 20 for 1 hour and sugar free gum brand received the control group and normal diet care regular received routine postoperative. All women feel the first movements Prystalysm gut feeling feelings first flatus and first bowel movement in the check list in order to make their mark.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012082610661N1
Registration date: 2013-01-04, 1391/10/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-01-04, 1391/10/15
Registrant information
Name
Farzaneh Rashidi Fakari
Name of organization / entity
Faculty of midwifer & nursing mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 1859 1511
Email address
rashidif901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research -Northern Khorasan University of Medical Science
Expected recruitment start date
2011-03-15, 1389/12/24
Expected recruitment end date
2011-12-15, 1390/09/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of chewing sugar-free gum on bowel function after cesarean section
Public title
effect of chewing on bowel function after cesarean
Purpose
Treatment
Inclusion/Exclusion criteria
(Inclusion criteria: Inclusion of satisfaction;Safe and non-emergency cesarean; Mothers aged 35-18 years; Parity 1-4; Infant health; During normal operation). (Exclusion criteria: amount of bleeding (more than 80 ml);Dissatisfaction with Research complicated)
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 92
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
North Khorasan University of Medical Sciences
Street address
Berenji street, Bojnord, North Khorasan
City
Bojnord
Postal code
Approval date
2011-03-15, 1389/12/24
Ethics committee reference number
225 89پ

Health conditions studied

1

Description of health condition studied
Start a bowel movement after cesarean
ICD-10 code
K92.8
ICD-10 code description
Other specified diseases of digestive system

Primary outcomes

1

Description
Start a bowel movement after cesarean
Timepoint
8, 14: 20 hours after intervention
Method of measurement
check list ofresearcher made

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group:Mothers receive the chewing of consciousness sugar free gum three times a day at 8, 14, 20 for 1 hour and sugar free gum brand received. Every mother feels the first movement Prytalysm intestinal feel the sense of first flatus and defecation in the check list in order to make their mark.
Category
Treatment - Other

2

Description
Control Group: The control group received a normal diet after surgery regular routine care. All women feel the first movements Prytalysm gut feeling feelings first flatus and first bowel movement in the check list in order to make their mark
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Maternity Bennet Huda
Full name of responsible person
Toba Frazmand
Street address
Maternity Bennet Huda, Bojnord
City
Bojnord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for research -North Khorasan University of Medical Science
Full name of responsible person
Arash Aabri
Street address
Vice-chancellor for research, Berenji street, Bojnord
City
Bojnord
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 -North Khorasan University of Medical Science
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
Faculty Nursing and Midwifery, Mashhad
Full name of responsible person
Farzaneh Rashidi Fakari
Position
Student of Msc
Other areas of specialty/work
Street address
Crossroads Doktora, Mashhad
City
Mashhad
Postal code
Phone
+98 511859151
Fax
Email
rashidif66@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Msc of midwifery
Full name of responsible person
Zohreh Abasi
Position
Msc
Other areas of specialty/work
Street address
Shahryar street, Bojnord
City
Bojnord
Postal code
Phone
00
Fax
Email
abasi_zohre_55@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty Nursing and Midwifery
Full name of responsible person
Farzaneh Rashidi Fakari
Position
Student of Msc
Other areas of specialty/work
Street address
Crossroads Doktora, Mashhad
City
Mashhad
Postal code
Phone
+95 5118591511
Fax
Email
rashidif66@yahoo.com
Web page address

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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