General Purpose :
The effect of tranexamic acid on post-cesarean hemorrhage in Motahhari hospital
Specific goals:
1. Determine the effect of TXA on reducing post-cesarean hemorrhage based on age of patients
2. Determine the effect of TXA on decreasing post-cesarean hemorrhage based on BMI in patients
3. Determine the effect of TXA on reducing post-cesarean hemorrhage based on parity in patients
Design
Non-probability sampling will be easy (available). Individuals will be randomly assigned to two groups and blocks A and B will be covered.
How to Calculate Sample Size: How to Calculate Sample Size:
According to the study by Bhavana G et al. In 2016, taking into account the following values and using the sample size formula, with 20% loss, 100 individuals (50 intervention group and 50 control group) were considered.
Settings and conduct
In the study group, the injection of 1.5 g (15) ccTXA before skin incision for cases weighing more than 90 kg and 1 g=10 cc before skin incision for cases weighing less than 90 kg. The control group will also have the same injection rate as the control group, with the exception of distilled water (1.5 g =15 cc) prior to skin incision for cases weighing more than 90 kg (1 g=10 cc) before Skin incision is used for cases weighing less than 90 kg
Participants/Inclusion and exclusion criteria
Single fetus and Elective Cesarean Section Referred to Motahhari Hospital for Delivery
Intervention groups
participants seprate two group with blind method and one group give tranexamic acid.
Main outcome variables
Blood loss after cesarean section
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140420017365N4
Registration date:2020-04-27, 1399/02/08
Registration timing:retrospective
Last update:2020-04-27, 1399/02/08
Update count:0
Registration date
2020-04-27, 1399/02/08
Registrant information
Name
Fatemeh Bahadori
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3223 7077
Email address
fbahadory27@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation Efficacy of Tranexamic acid in decreasing blood loss in cesarean delivery
Public title
Evaluation Efficacy of Tranexamic acid in decreasing blood loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for Elective Singleton Cesarean section
Having adequate prenatal care.
Complete the form of informed consent
Age range 18-45 years
Exclusion criteria:
Patients do not accept to participate in the study
They have anemia and bleeding diseases or serious medical or surgical diseases
Sensitivity to Tranexamic acid
Fetal macrosomia
Thromboembolism Score(V.T.E. scoring)≥3
Placental Abruption , placenta parvia and abnormal placental adherence
Uterine myoma more than 5 cm
Polyhydramnios
Multi-fetus pregnancy
Use of Anticoagulant such as enoxaparin or heparin
Severe pregnancy complications such as preeclampsia
Long-term hospitalization more than 3 days before cesarean section
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization method or block randomization. With 8 blocks of patients
Blinding (investigator's opinion)
Triple blinded
Blinding description
Randomized (by Block Randomization method) with 8 blocks of patients (individuals in one of two tranexamic acid recipient groups) study group (or distilled water group) control group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Urgent Street, Resalat Blvd, Urmia , Iran
City
Urmia
Province
West Azarbaijan
Postal code
Postal Code:57147833
Approval date
2019-07-31, 1398/05/09
Ethics committee reference number
IR.UMSU.REC.1398.189
Health conditions studied
1
Description of health condition studied
Blood loss after cesarean
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Blood loss
Timepoint
After cesarean section
Method of measurement
Bleeding volume including suctioned blood volume, weight of all draw sheets changed up to 6 hours after surgery
2
Description
Blood transfusion
Timepoint
Blood transfusions and blood products at admission time
Method of measurement
number of transfused blood products
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Intravenus Injection of tranexamic acid 1.5or1gram to pateints before the onset of cesarean.it is a fibrinolytic agent that reduce the blood loss in surgery.this ampules are 500 mg and we inject two or tree ampule .this ampoules manufactured by caspian tamin.
Category
Treatment - Drugs
2
Description
Control group: Injection of sterilized water 10 or15 cc according to patients BMI ;below 90kg and above 90 kg ;before cesarean section in control group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahhari Hospital
Full name of responsible person
Fatemeh Bahadori
Street address
Kowsar center, Motahhari Hospital, Kashani St., Urmia
City
Urmia
Province
West Azarbaijan
Postal code
57147
Phone
+98 44 3223 7077
Email
bahadory27@yahoo.com
Web page address
https://motahari.umsu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Iraj Mohebbi
Street address
Orjhans Street, Resalat Blvd, Urmia , Iran
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3223 4897
Email
mohebbi_iraj@yahoo.co.uk
Web page address
https://english.umsu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Maryam Nikpour
Position
rezident of gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
kashani street/Motahari hospital
City
Urmia
Province
West Azarbaijan
Postal code
04412234125
Phone
0442237077
Fax
+98 44 1223 4125
Email
Maryamnikpour1367@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Maryam Nikpour
Position
Rezident of gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
kashani st.motahari hospital
City
Urmia
Province
West Azarbaijan
Postal code
04412234125
Phone
0442237077
Email
Maryamnikpour1367@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Maryam Nikpour
Position
Rezident of gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
kashani st.motahari hospital
City
Urmia
Province
West Azarbaijan
Postal code
04412234125
Phone
0442237077
Email
Maryamnikpour1367@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
Non-demographic data files, including the main study variables, are published online in Excel format.
When the data will become available and for how long
The data will be published after the publication of the protocol paper and the original paper of the study results by the corresponding researcher.
To whom data/document is available
The data will be available online without any request.
Under which criteria data/document could be used
For analysis and study by other interested researchers
From where data/document is obtainable
The data will be available online
What processes are involved for a request to access data/document
The data will be available online without any request.