Investigating the effectiveness of the simultaneous use of Tranexamic acid and Oxytocin compared to the use of Oxytocin alone on the amount of bleeding after caesarean section .
Investigating the effectiveness of the simultaneous use of Tranexamic acid and Oxytocin compared to the use of Oxytocin alone in reducing the amount of bleeding after caesarean section in patient of Afzalipour Hospital in Kerman in 2023.
Design
Clinical trial with intervention and control groups, with parallel group design, double blind, randomized, phase 3, on 140 patients, Simple systematic division was used for randomization.
Settings and conduct
Place of study: Women's operating room of Afzalipur Hospital, Kerman.
Study population: Selection of 140 candidates for elective or emergency caesarean section referred to Afzalipur Kerman Hospital in 1402 after checking the exclusion criteria.
Type of blinding: double blind.
How to blind: The researcher selects the patient's card and if the card is from the intervention group, informs the nurse to inject The Oxytocin and Tranexamic acid and if the patient is from the control group, only to inject it with Oxytocin. The doctor and the patient do not know which patient is from the intervention group and which one is from the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who referred to Afzalipour Kerman Hospital for elective or emergency caesarean section in 2023.
Exclusion criteria: Patients with acreta and previa placentas; history of uterine atony; history of uterine rupture; history of coagulation disorders; history of myomectomy; Patients with chorioamnionitis; Patients with hematologic disorders.
Intervention groups
Control group: In the third stage of labor, only 40 units of Oxytocin are injected intramuscular( IM) by the nurse to 70 patients.
Intervention group: In the third stage of labor; in addition to 40 units of Oxytocin( intramuscular), 10 mg per kg of patient's weight of Tranexamic acid is injected intravenously (IV) to 70 patients.
Main outcome variables
The amount of bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230307057644N2
Registration date:2024-07-30, 1403/05/09
Registration timing:retrospective
Last update:2024-07-30, 1403/05/09
Update count:1
Registration date
2024-07-30, 1403/05/09
Registrant information
Name
Ghazal Mansouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 399 7804
Email address
mansori@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
2023-05-22, 1402/03/01
Actual recruitment end date
2024-06-09, 1403/03/20
Trial completion date
2024-06-09, 1403/03/20
Scientific title
Investigating the effectiveness of the simultaneous use of Tranexamic acid and Oxytocin compared to the use of Oxytocin alone on the amount of bleeding after caesarean section .
Public title
Investigating the effect of Tranexamic acid in bleeding after caesarean section.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who referred to Afzalipour Kerman Hospital for elective or emergency caesarean section in 2023.
Exclusion criteria:
Patients with placenta Accreta and previa.
Patients who have a history of uterine atony.
Patients who have a history of uterine rupture.
Patients who have a history of coagulation disorders.
Patients with chorioamnionitis.
Patients with hematologic disorders.
Patients who have a history of myomectomy.
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
140
Actual sample size reached:
140
Randomization (investigator's opinion)
Randomized
Randomization description
We prepare some cards according to the sample size. On half of the cards we write intervention group and on the other half we write the control group. We put the cards in a basket. Then we randomly select them from the basket. After choosing each card, we number them in order and in the last stage according to the number of cards; we put them together. For example, card number 1 is the intervention group, card number 2 is the control group, card number 3 is the control group, etc. Then, without the patient or the doctor noticing, the researcher selects a card for each patient in the order we put and each patient is assigned to the intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double blind, the researcher selects the patient's card and if the card is from the intervention group, informs the nurse to inject The Oxytocin and Tranexamic acid and if the patient is from the control group, only to inject it with Oxytocin. The doctor and the patient do not know which patient is from the intervention group and which one is from the control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Kerman University of Medical Science, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2023-02-28, 1401/12/09
Ethics committee reference number
IR.KMU.AH.REC.1401.290
Health conditions studied
1
Description of health condition studied
Postpartum hemorrhage
ICD-10 code
O72
ICD-10 code description
Postpartum hemorrhage
Primary outcomes
1
Description
The amount of bleeding
Timepoint
Measuring the patient's hemoglobin before delivery and 6 hour after delivery.
Method of measurement
Blood test for complete blood cells( CBC).
Secondary outcomes
1
Description
Requirement to blood transfusions (Packed cell) and blood products (Platelets and Fresh Frozen Plasma).
Timepoint
During delivery, 6 hours after delivery and one turn within the first 24 hours after delivery.
Method of measurement
Due to the volume of bleeding during delivery and the rate of decrease in hemoglobin in the blood test.
2
Description
Uterine atony
Timepoint
It is checked every 15 minutes in the first hour after delivery, every 30 minutes in the second hour after delivery, and then during the first 2 to 24 hours after delivery.
Method of measurement
Frequent examination of the uterine fundus.
3
Description
The need to use uterotonic drugs such as Methergin, Misoprostol, Factor 7, Prostaglandin.
Timepoint
During delivery and the first 24 hours after delivery
Method of measurement
According to the amount of bleeding, which medicine was used based on the opinion of the obstetrician and gynecologist.
4
Description
The need to use a Bakri Balloon
Timepoint
During delivery and the first 24 hours after delivery
Method of measurement
According to the amount of bleeding, a Bakri Balloon is inserted based on the opinion of the obstetrician and gynecologist.
5
Description
The need for surgery to remove the uterus (hysterectomy)
Timepoint
During delivery and the first 24 hours after delivery
Method of measurement
According to the amount of bleeding, hysterectomy is performed based on the opinion of the obstetrician and gynecologist.
Intervention groups
1
Description
Control group: In the third stage of labor, only 40 units of Oxytocin are injected intramuscular( IM) by the nurse to 70 patients included in the study.
Category
Treatment - Drugs
2
Description
Intervention group: In the third stage of labor; in addition to 40 units of Oxytocin( intramuscular), 10 mg per 1 kg of patient weight of Tranexamic acid is injected intravenously( IV) to 70 patients.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Ghazal Mansouri
Street address
Imam Khomeini Highway, next to Shahid Bahonar University, Afzalipour Medical Education Center
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
mansori@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza Malekpour Afshar
Street address
Kerman, the beginning of Haft Bagh Alavi axis, University of Medical Sciences campus
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
r_malekpoor@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Ghazal Mansouri
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
University of Medical Sciences campus, at the beginning of Haft Bagh Alavi axis
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
mansori@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Ghazal Mansouri
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
University of Medical Sciences campus, at the beginning of Haft Bagh Alavi axis
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
mansori@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Ghazal Mansouri
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
University of Medical Sciences campus, at the beginning of Haft Bagh Alavi axis
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
mansori@kmu.ac.ir
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
Total data
When the data will become available and for how long
Starting from six months after the publication of the article.
To whom data/document is available
Researchers, students and doctors
Under which criteria data/document could be used
To conduct clinical trial
From where data/document is obtainable
Public or scientific responsible person
What processes are involved for a request to access data/document
Send the proposal to the responsible persons email; mansori@kmu.ac.ir