IRCT | 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 .

Protocol summary

Study aim: 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 163 patients, Simple systematic division was used for randomization.
Settings and conduct: Place of study: Women's operating room of Afzalipour Hospital, Kerman. Study population: Selection of 163 candidates for elective or emergency caesarean section referred to Afzalipour 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 30 units of Oxytocin are injected intramuscular( IM) by the nurse to 82 patients. Intervention group: In the third stage of labor; in addition to 30 units of Oxytocin (intramuscular), 1 g of Tranexamic acid is injected intravenously (IV) to 81 patients.
Main outcome variables: The amount of bleeding

General information

Reason for update: This study was conducted with a larger sample size.
Acronym
IRCT registration information: IRCT registration number: IRCT20230307057644N2

Registration date: 2024-07-30, 1403/05/09

Registration timing: retrospective

Last update: 2026-02-11, 1404/11/22

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: 163

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

Medical University Campus, Kerman University of Medical Science, Haft-Bagh Highway, Kerman

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 30 units of Oxytocin are injected intramuscular (IM) by the nurse to 82 patients included in the study.
Category: Treatment - Drugs

2

Description: Intervention group: In the third stage of labor; in addition to 30 units of Oxytocin (intramuscular), 1 g of Tranexamic acid is injected intravenously (IV) to 81 patients.
Category: Treatment - Drugs

Recruitment centers

1

Recruitment center: Name of recruitment center

Afzalipour Hospital

Full name of responsible person

Ghazal Mansouri

Street address

Afzalipour Medical Education Center, next to Shahid Bahonar University, Imam Khomeini Highway

City

Kerman

Province

Kerman

Postal code

7616913355

Phone

+98 34 3132 8000

Email

mansori@kmu.ac.ir

1

Sponsor: Name of organization / entity

Kerman University of Medical Sciences

Full name of responsible person

Reza Malekpour Afshar

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

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
Comments

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 .