This study is a randomized controlled trial study that will be done on 90 women from the 22 December 2013 to 21 March 2014 at the Emam khomeini Hospital in Sari will be delivered by cesarean section .Intervention Group are consisted of 45 cases that drink 20 ml of the syrup that has 2 mg of Carum Carvi in two half-hour interval, 6 hours after surgery. Control group are consisted of 45 cases that drink 20 ml of the placebo in two half-hour interval, 6 hours after surgery. These groups will be observed under the routine care after cesarean. Thus, their feeding will be started after bowel sounds auscultation and flatus, with clear liquid. Soft and normal diet will be started after defecation. We have to check the sounds of bowel every 30 minutes until it will be heard, the time to the first passage of flatus and defecation and bowel motility and Coming down from the bed and the time until the discharge from the hospital will be completed by patient in a special check list. Measurable results are: the time of first bowel sounds auscultation, first flatus, first bowel motility and hospital discharge. Data using SPSS-17 software and descriptive and inferential statistical tests (chi-square, T test, ANOVA and paired comparisons) will be analyzed. In this study, P <0.05 was considered as statistically significant.
General information
Acronym
The effect of Carum carvi
IRCT registration information
IRCT registration number:IRCT2013082614486N1
Registration date:2013-12-28, 1392/10/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-28, 1392/10/07
Registrant information
Name
Seyed Sedighe Yoosefi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1325 4066
Email address
s-yousefi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
This study is funded by Tehran University of Medical Sciences.
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of selective production base on Carum carvi on early return of bowel motility after caesarean section
Public title
The effect of selective production base on Carum carvi on early return of bowel motility after caesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: fasting for at least 8 hours before surgery; received a maximum of 4 doses of intravenous antibiotics; having a gestational age of 42-38 weeks; having good vital signs; no unusual complications of surgery; absence of fever before operation; lack of medical disorders and obstetric patients addicted to cigarettes and illegal drugs are not. Exclusion criteria: the patient withdrew from the study, those at risk for ileus and aspiration ( background radiation , anastomotic stricture , peptic ulcer, esophagitis, intestinal obstruction ), a lot of individuals taking sedatives, obstetric complications such as fatty liver of pregnancy, preeclampsia, diabetes, placental abruption, chorioamnionitis, post-operative complications ( atonic uterus, antibiotic therapy, more than four doses ), intraoperative complications ( severe adhesion, blood transfusion, injury to bowel and bladder ), personal discharge, during over 90 minutes, the use of magnesium sulfate for the possibility of nausea, infection, hypothyroidism, hyperparathyroidism, neuromuscular disease, excessive intestinal manipulation is obvious.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Questionnaire by a person who is unaware of the grouping of the subjects will be completed.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Faculty of Traditional Medicine, Tehran University of Medical Sciences
Street address
Islamic Medicinal Research Institute, Pirnia Ave., Lalehzar St., Tehran, Iran
City
Tehran
Postal code
Approval date
2013-05-27, 1392/03/06
Ethics committee reference number
115/م/ط/پ/26
Health conditions studied
1
Description of health condition studied
Postoperative intestinal obstruction
ICD-10 code
K91.3
ICD-10 code description
Postoperative intestinal obstruction
Primary outcomes
1
Description
Bowel sound
Timepoint
Each half-hour intervals , one hour after the intervention until the first sound will be heard
Method of measurement
Bowel sound auscultation by Stethoscope
2
Description
Flatus
Timepoint
First flatus
Method of measurement
Check list
3
Description
Defecation
Timepoint
The first defecation after caesarean
Method of measurement
Check list
4
Description
The time of discharge
Timepoint
At discharge
Method of measurement
Check list or file
Secondary outcomes
1
Description
Bloat
Timepoint
Befor and after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
This study will be done on 90 women from the 22 December 2013 to 21 March 2014 at the Emam khomeini Hospital in Sari will be delivered by cesarean section .Intervention Group are consisted of 45 cases that drink 20 ml of the syrup that has 2 mg of Carum Carvi in two half-hour interval, 6 hours after surgery. This group will be observed under the routine care after cesarean. Thus, their feeding will be started after bowel sounds auscultation and flatus, with clear liquid. Soft and normal diet will be started after defecation. We have to check the sounds of bowel every 30 minutes until it will be heard, the time to the first passage of flatus and defecation and bowel motility and Coming down from the bed and the time until the discharge from the hospital will be completed by patient in a special check list.
Category
Treatment - Drugs
2
Description
Control group are consisted of 45 cases that drink 20 ml of the placebo in two half-hour interval, 6 hours after surgery. This group will be observed under the routine care after cesarean. Thus, their feeding will be started after bowel sounds auscultation and flatus, with clear liquid. Soft and normal diet will be started after defecation. We have to check the sounds of bowel every 30 minutes until it will be heard, the time to the first passage of flatus and defecation and bowel motility and Coming down from the bed and the time until the discharge from the hospital will be completed by patient in a special check list.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sari Emam Khomeini hospital
Full name of responsible person
Zoleikha Atarod Gynecologist and Head of Department
Street address
Amir Mazandarani Av.
City
Sri
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dr. Minaei; Vice chancellor for research Traditional Medicine Faculty of Tehran University of Medica
Full name of responsible person
Dr. Minaei
Street address
Behesht Street, Vahdat eslami Ave.
City
Tehran
Grant name
فرناز سهرابوند
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dr. Minaei; Vice chancellor for research Traditional Medicine Faculty of Tehran University of Medica
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
Traditional Medicine Faculty, Tehran University of Medical Sciences
Full name of responsible person
Seyde Sedighe Yosefi
Position
PhD candidate
Other areas of specialty/work
Street address
Behesht Ave., Vahdat eslami St.
City
Tehran
Postal code
4818786481
Phone
+98 15 1325 4066
Fax
Email
dr_ssyosefi@yahoo.com; s-yousefi@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Farnaz Sohrabvand
Position
Associated professor
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Keshavar Boulevard
City
Tehran
Postal code
Phone
+98 21 6119 2741
Fax
+98 21 6643 7749
Email
fsohrabvand@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Traditional Medicine Faculty, Tehran University of Medical Sciences
Full name of responsible person
Seyde Sedighe Yosefi
Position
PhD candidate
Other areas of specialty/work
Street address
Behesht Ave., Vahdat eslami St.
City
Tehran
Postal code
Phone
+98 21 5563 9723
Fax
+98 21 6522 6043
Email
dr_ssyosefi@yahoo.com; s-yousefi@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)