Determining the effect of fennel extract compared to placebo on improving intestinal function after cesarean section
Design
Based on the random sequence produced by the statistical consultant, the samples are randomly placed in two intervention groups and control groups. The random sequence will be generated by the method of random blocks of 4.
Settings and conduct
This study is a randomized controlled clinical trial. The target population in this study will be all patients who are candidates for cesarean section who are admitted to Shahid Mobini Hospital of Sabzevar University of Medical Sciences. The study sample will include all women candidates for cesarean section who meet the entry and exit criteria and are willing to participate in the study. Based on the random sequence produced by the statistical consultant, the samples are randomly placed in two intervention groups and control groups. The random sequence will be generated by the method of random blocks of 4.
Participants/Inclusion and exclusion criteria
All the wemen with cesarian section
Intervention groups
Starting a liquid diet in caesarean section patients and drops of fennel essential oil every 4 hours up to three times
Main outcome variables
The results of the study include the time of the first gas passage after surgery, the time of the first bowel movement after surgery, the time of starting an oral diet, the amount of pain medication needed, and the symptoms of ileus including nausea, vomiting, abdominal pain, and the rate of postoperative complications and duration. It is a bed that will be registered every 4 hours from 2 hours after surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231212060348N1
Registration date:2024-06-09, 1403/03/20
Registration timing:prospective
Last update:2024-06-09, 1403/03/20
Update count:0
Registration date
2024-06-09, 1403/03/20
Registrant information
Name
Elham Gharib
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4466 2863
Email address
gharibelham1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of fennel extract on improving bowel movements (ileus) after cesarean section
Public title
Investigation of fennel extract in digestive problems after caesarean section
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Recent cesarean section
Exclusion criteria:
gas passing and defication befor taking medicen
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, the principal investigator, especially in trials initiated by Sabzevar academic researchers, health care personnel (doctors, nurses, etc.) who are responsible for patient care, those responsible for data collection, and those who evaluate outcomes. and to a lesser degree, the Data Safety and Monitoring Board Committee and those who prepare the draft of the article
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sabzevar University of Medical Sciences
Street address
West corner of Pasdaran 8, second floor
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618636535
Approval date
2023-11-13, 1402/08/22
Ethics committee reference number
IR.MEDSAB.REC.1402.076
Health conditions studied
1
Description of health condition studied
Ileus after caesarean section
ICD-10 code
K56.7
ICD-10 code description
Ileus, unspecified
Primary outcomes
1
Description
En Percentage of people who have ileus after cesarean section
Timepoint
4 to 6 hours after cesarean section
Method of measurement
Questionnaire under nurse supervision
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Recipients of fennel extract to investigate the effect of the drug on digestive problems after cesarean section.Based on the random sequence produced by the statistical consultant, the samples are randomly placed in two intervention groups and control groups. A random sequence will be produced by the method of random blocks of 4. A full explanation of the research method has been given for all the samples, and the samples will be included in the study after completing the written consent form. Before starting the intervention, a questionnaire based on demographic and clinical characteristics is completed for each person participating in the research. All samples must not have received anything by mouth for at least 8 hours before the procedure. Information related to surgery, including the type of anesthesia, type of skin incision, type of uterine incision, length of operation, blood transfusion, adhesions and complications during operation are recorded in the operating room based on the patient's file.In the intervention group, starting the liquid diet, they will receive drops of fennel essential oil up to three times every 4 hours. Patients in the control group will receive a placebo in the same way. Both groups are also subjected to routine ward care. The protocol for prescribing anesthetic drugs and antibiotic regimen is the same for all samples. Patients are encouraged to start walking 12 hours after the operation. All medications received are recorded in the questionnaire. The discharge of the patient will be based on the presence of gas and feces and the tolerance of the oral diet, the absence of complications after the operation and at the discretion of the surgical staff.
Category
Early detection
2
Description
Control group:placebo recipients
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mobini hospital in Sabzevar city
Full name of responsible person
Elham Gharib
Street address
West corner of Pasdaran 8, Second floor
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618636535
Phone
+98 51 4465 2498
Email
Gharibelham1@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Kazem Hasanpour
Street address
University of Medical Sciences Campus, Research and Technology Vice-Chancellor, Block B
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618636535
Phone
+98 51 4401 8103
Email
Gharibelham1@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Elham Gharib
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
West corner of Pasdaran 8, Second floor
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618636535
Phone
+98 51 4465 2498
Email
Gharibelham1@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Elham Gharib
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
West corner of Pasdaran 8, Second floor
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618636535
Phone
+98 51 4465 2498
Email
Gharibelham1@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Elham Gharib
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
West corner of Pasdaran 8, Second floor
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618636535
Phone
+98 51 4465 2498
Email
Gharibelham1@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available