Protocol summary

Study aim
Determining the comparative study of the effect of carbutocin and oxytocin with and without tranexamic acid on the amount of bleeding and hemoglobin level in cesarean delivery.
Design
A clinical trial with a control group, with a factorial design, randomized, double-blind, two-mode
Settings and conduct
In this study, the patients will be included in the study after the informed consent will be obtained from the eligible patients referring to the maternity department of Beheshti Hospital in Kashan and the Kashan Imitation Maternity Hospital. The study is double-blind, and the examining resident and drug provider will not know the type of treatment. After taking a detailed history and complete physical examination, CBC, BG and RH tests and the patient's blood pressure were measured. People will be divided into two groups based on natural birth and caesarean section. In this study, a researcher-made demographic questionnaire including age, ethnicity, amount of bleeding, number of births, etc. will be used to collect information
Participants/Inclusion and exclusion criteria
Inclusion criteria Patients over 18 years old Consent to participate in the research being married Exit criteria Contraindications of drugs used in the study Known bleeding diseases High diastolic blood pressure Recent use of non-steroidal anti-inflammatory drugs history of severe anemia; Allergy and recent blood transfusion intra-abdominal adhesions during surgery, Bladder and intestine damage and other viscera during surgery, Abnormal attachment of the placenta to the uterus and expansion of the uterine incision during cesarean section Preeclampsia High-risk pregnancies such as triplets, polyhydramnios
Intervention groups
Group A is oxytocin and tranexamic acid, group B is oxytocin, group C is carbetocin and tranexamic acid, and group D is cartocin.
Main outcome variables
Bleeding volume, hemoglobin level

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240529061944N1
Registration date: 2024-06-14, 1403/03/25
Registration timing: registered_while_recruiting

Last update: 2024-06-14, 1403/03/25
Update count: 0
Registration date
2024-06-14, 1403/03/25
Registrant information
Name
Delaram Beyrami
Name of organization / entity
Kashan Faculty of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5558 9444
Email address
delarambeyrami@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-18, 1403/01/30
Expected recruitment end date
2024-07-20, 1403/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of carbetocin and oxytocin with and without tranexamic acid on amount of bleeding and hemoglobin level in cesarean section
Public title
Comparison of two drugs, carbutocin and oxytocin, with and without tranexamic acid in cesarean section bleeding rate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years old, Consent to participate in the researchbeing, married
Exclusion criteria:
Age
From 18 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Considering that this study is a randomized clinical trial with a 2*2 factorial design. According to the type of delivery (natural or caesarean section), all patients are assigned to 4 treatment groups and a total of 8 groups. In this way, you must first choose the type of delivery and choose the main and auxiliary drugs. receives. Randomization is done by block method (Permuted blocked randomization) with blocks of four (4 blocks in total). The method for easy work from Clin Trial Randomization software is group A, oxytocin and tranexamic acid, group B, oxytocin, group C, carbetocin and tranexamic acid, and group D, cartocin. According to the table obtained from the randomization software, which of the above groups is prescribed to the patients in order. In all groups, there is a uterotonic drug that is necessary for the contraction of the uterine muscle after the baby is born. In each group A, B, C, D, 2 syringes are ready for injection, one of them contains utrotonic and the other one contains tranexamic acid or empty normal saline as a placebo. The homogenization of the drugs is that 30 units of oxytocin and 100 micrograms (1 ampoule) each are dissolved in 0.9% normal saline serum to a volume of 10 cc and drawn and homogenized in the same syringes. 500 mg of tranexamic acid is dissolved in 0.9% normal saline and reaches a volume of 10 cc, and is equalized against 10 cc of 0.9% normal saline serum drawn in the same syringes. Randomly, the sick midwife During a natural delivery and during a cesarean section, after the birth of the baby, the anesthesia technician injects two intravenous syringes from the drug group belonging to the patient who was separated according to the table.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kashan University
Street address
5 km of Qutb Ravandi Blvd
City
Kashan
Province
Kurdistan
Postal code
0365551112
Approval date
2024-03-16, 1402/12/26
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1402.285

Health conditions studied

1

Description of health condition studied
Cesarean section
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Bleeding volume, hemoglobin level
Timepoint
Before delivery, after delivery
Method of measurement
Measurement of suction blood volume, gas and langaz during operation and hemoglobin test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Group A, oxytocin and tranexamic acid, group B, oxytocin, group C, carbetocin and tranexamic acid, and group D, cartocin.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
The maternity ward of Beheshti Hospital in Kashan and the maternity hospital of Kashan
Full name of responsible person
Delaram beyrami
Street address
5 km of Qutb Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
03615551112
Phone
+98 912 457 5568
Email
Delarambeyrami@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Delarambeyrami
Street address
Kashan
City
Kashan
Province
Isfehan
Postal code
00365551112
Phone
+98 912 457 5568
Email
Delarambeyrami@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Delaram beyrami
Position
Student
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
5 km of Qutb Rawandi Blvd
City
Kashan
Province
Isfehan
Postal code
00365551112
Phone
+98 912 457 5568
Email
Delarambeyrami@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Delaram beyrami
Position
Student
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
5 km of Qutb Rawandi Blvd
City
Kashan
Province
Isfehan
Postal code
00365551112
Phone
+98 912 457 5568
Email
Delarambeyrami@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Delaram beyrami
Position
Student
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
5 km of Qutb Rawandi Blvd
City
Kashan
Province
Isfehan
Postal code
00365551112
Phone
+98 912 457 5568
Email
Delarambeyrami@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data that is published is related to the results of the study, including the impact of the intervention on the main and secondary outcomes, and the demographic data of the people remains protected.
When the data will become available and for how long
The access period starts from 1403 and 6 months after publication
To whom data/document is available
Researchers and doctors working in the field of obstetrics and gynecology
Under which criteria data/document could be used
If information about the impact of the intervention on secondary outcomes is needed
From where data/document is obtainable
Email of the responsible person
What processes are involved for a request to access data/document
The data will be provided to the person in charge within 48 hours after the email
Comments
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