The purpose of this clinical trial study is compared the outcome of post-operative outcomes associated with early oral feeding (after 2 hours) versus late oral feeding (after 8 hours) following cesarean section. A total of 140 pregnant women more than 37 weeks with gestational age who will undergo the cesarean section procedure in Imam Reza hospital during one year randomly were recruited. The patients who are admitted for emergency cesarean, General anesthesia or more than 1000 cc blood loss during the operation are excluded. The main outcomes are duration of hospitalization, bowel movement resumption time, Flatus passing and defecation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012102411245N1
Registration date:2012-12-02, 1391/09/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-02, 1391/09/12
Registrant information
Name
Nasrin Jalilian
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1427 6301
Email address
njalilian@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2011-08-23, 1390/06/01
Expected recruitment end date
2013-04-21, 1392/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To compare outcomes of oral feeding 2 and 8 hours after cesarean section under regional anesthesia in term pregnant women
Public title
Comparing the effect of post-operative outcomes early vs. late oral feeding after Cesarean section
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women more than 37 weeks; elective cesarean section; regional anesthesia; after signing the informed consent.
Exclusion criteria:
Emergency cesarean section; general anesthesia; more than 1000 ml blood loss during operation; use of magnesium sulfate; gastrointestinal disorders and complications during surgery such as bowel and bladder injury.
Age
From 17 years old to 41 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
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
Kermanshah University of Medical Sciences
Street address
Maternity Research Center, OB & GYN Department, Imam Reza hospital, Parastar Blvd, Sorkheh Lyjeh
City
Kermanshah
Postal code
Approval date
2011-10-13, 1390/07/21
Ethics committee reference number
28305/420/7
Health conditions studied
1
Description of health condition studied
Cesarean
ICD-10 code
O82
ICD-10 code description
Single delivery by caesarean section
Primary outcomes
1
Description
Bowel movement resumption time
Timepoint
Every 6 hours for 48 hours
Method of measurement
In hours, the time after the surgery until hearing bowel sounds with stethoscope
2
Description
Duration of hospitalization
Timepoint
After patients discharge
Method of measurement
Evaluation of patient document
3
Description
Flatus passing
Timepoint
Every hour
Method of measurement
Asking from patients
4
Description
Defecation
Timepoint
Every hour
Method of measurement
Asking from patients
Secondary outcomes
1
Description
Surgical incision complications
Timepoint
Daily in 48 hrs after surgery and also in Fifteenth day.
Method of measurement
Such as seruma ,hematoma, abscesses, wound dehiscence
2
Description
Permanent fever after the surgery
Timepoint
During 48 hrs after surgery, measured every 3 hours
Method of measurement
Persist fever after more than 38 ° c, with thermometer
3
Description
Urinary Tract Infection
Timepoint
During 48 hrs after surgery
Method of measurement
Through a urine test
4
Description
Hospital Readmission
Timepoint
Baseline, the first, second , third, and fourth week after the intervention
Method of measurement
Visual analog scale of readmission
Intervention groups
1
Description
Control group: Oral feeding after 8 hours
Category
Treatment - Other
2
Description
Intervention group: Oral feeding after 2 hours
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecology ward of Imam Reza Hospital
Full name of responsible person
Dr.Nasrin Jalillian
Street address
Obs & Gynecology department, Imam Reza hospital, Parastar blvd, Sorkheh lyjeh, Kermanshah University of Medical Sciences (KUMS), Kermanshah, Islamic Republic of Iran .
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences (KUMS )
Full name of responsible person
Dr. Farid Najafi
Street address
Imam Reza hospital, Parastar blvd, Sorkheh lyjeh, Kermanshah University of Medical Sciences (KUMS), Kermanshah, Islamic Republic of Iran.
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences (KUMS )
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
Kermanshah University of Medical Sciences (KUMS ).
Full name of responsible person
Leila Mirdamadi
Position
Obs & Gyn resident
Other areas of specialty/work
Street address
Obs & Gynecology department, Imam Reza hospital, Parastar blvd, Sorkheh lyjeh, Kermanshah University of Medical Sciences (KUMS), Kermanshah, Islamic Republic of Iran .
City
Kermanshah
Postal code
Phone
+98 83 1836 6825
Fax
Email
mrc.kums@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences (KUMS )
Full name of responsible person
Dr.Nasrin Jalillian
Position
Infertility fellowship, Gynecologist and Obstetrician
Other areas of specialty/work
Street address
Obs & Gynecology department, Imam Reza hospital, Parastar blvd, Sorkheh lyjeh, Kermanshah University of Medical Sciences (KUMS), Kermanshah, Islamic Republic of Iran .
City
Kermanshah
Postal code
Phone
+98 83 1427 6310
Fax
Email
njalililan@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sara Daeichin
Position
Obstetrics (BCs) Of Maternity Research Center
Other areas of specialty/work
Street address
Obs & Gynecology department, Imam Reza hospital, Parastar blvd, Sorkheh lyjeh, Kermanshah University of Medical Sciences (KUMS), Kermanshah, Islamic Republic of Iran
City
Kermanshah
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)