Protocol summary

Study aim
The aim of this study was to evaluate the effect of preventive injection of tranexamic acid ampules on blood volume lost after cesarean delivery.
Design
In practice, the volume of blood in the suction (the volume of amniotic fluid from the blood that has accumulated in the suction) and the weight of the gauze and blood-stained tampons will be used to check for postpartum hemorrhage. A perfectly wet 4 x 4 cm gas holds about 10 cc of blood (28). A digital scale (with an error rate of 10 grams) will be used to weigh gases and guns. Postpartum hemorrhage is defined as a person losing 1,000 cc or more of blood after a cesarean section. To collect the blood lost after the cesarean section, immediately after the end of the cesarean section, a disposable plastic cover with a certain weight is spread under the cesarean section woman and she will be weighed 2 hours after the cesarean section.
Settings and conduct
The study population included women eligible for cesarean section in Izadi Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria included age 18-35 years, single pregnancy, cesarean delivery, blood pressure less than 140 over 90, no history of thromboembolism, no uterine myoma, no IUFD fetus, no decolonization and no history or active heart disease , Hepatic and renal. During cesarean section, if placental adhesions such as placenta, increta and percorta are observed, individuals will be excluded.
Intervention groups
The case group received 10 mg / kg tranxamic acid ampoule (made by Kharazmi Company) by slow intravenous injection (1 cc / min) immediately before cesarean section and the control group received intravenous sodium chloride (distilled water) ampoule at the same dose as the intervention group. Will receive.
Main outcome variables
Lost blood volume and hemoglobin and hematocrit levels before and 12-24 hours after delivery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20091010002558N7
Registration date: 2020-12-08, 1399/09/18
Registration timing: retrospective

Last update: 2020-12-08, 1399/09/18
Update count: 0
Registration date
2020-12-08, 1399/09/18
Registrant information
Name
Esmat Jafarbegloo
Name of organization / entity
Qom university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 1722 5100
Email address
jafarbegloo@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-03-21, 1395/01/02
Expected recruitment end date
2017-04-03, 1396/01/14
Actual recruitment start date
2016-03-21, 1395/01/02
Actual recruitment end date
2017-04-03, 1396/01/14
Trial completion date
2017-04-03, 1396/01/14
Scientific title
Effect of prophylactic intravenous tranexamic acid on blood loss after cesarean delivery
Public title
Effect of prophylactic intravenous tranexamic acid on blood loss after cesarean delivery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria included age 18-35 years, single pregnancy, cesarean delivery, blood pressure less than 140 over 90, no history of thromboembolism and coagulation disease, no uterine myoma, no IUFD fetus, no decolonization and no history or Active heart, liver and kidney diseases
Exclusion criteria:
During cesarean section, if placental adhesions such as placenta, increta and percorta are observed, individuals will be excluded.
Age
From 18 years old to 35 years old
Gender
Female
Phase
1
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 44
Actual sample size reached: 44
Randomization (investigator's opinion)
Randomized
Randomization description
The research population is randomly divided into two groups of intervention and control. Random assignment of patients to two groups is based on the block method. Block size 4 is considered. So we have six quadruple blocks consisting of AABB, ABAB, BBAA, BABA, ABBA, BAAB. The selection of each block will also be random and will be done using dice. For example, if the number 3 is rolled in a dice, the BBAA block is considered, so the first two patients are assigned to treatment B and the next two patients to treatment A. The dice will be thrown ten times to complete the assignment of patients to treatment groups. Assignment of treatment to groups A and B will also be based on accident (coin toss).
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to hide the medication allocation, two vials of the tranexamic acid and distilled water were placed in similar opaque sequentially numbered sealed packages by an Operator room technician that not involved in sampling and analysis, who maintained the medication administration code. In this way, the data evaluators and participants had no knowledge of the study medication.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Qom University of Medical Sciences
Street address
saheli street
City
Qom
Province
Ghoum
Postal code
3715835155
Approval date
2016-02-10, 1394/11/21
Ethics committee reference number
MUQ.REC.1394.154

Health conditions studied

1

Description of health condition studied
postpartum blood loss
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
blood loss after cesarean
Timepoint
The lost blood will be controlled in two times: A: The time of placenta departure until the end of cesarean section B: From the end of cesarean section to 2 hours after delivery.
Method of measurement
In practice, the volume of blood in the suction and the weight of the gases and blood-stained tampons will be used to check for postpartum hemorrhage. A digital scale (with an error rate of 10 grams) will be used to weigh gases and guns. To collect the blood lost after the cesarean section, immediately after the end of the cesarean section, a disposable plastic cover with a certain weight is spread under the cesarean section woman and she will be weighed 2 hours after the cesarean section.

2

Description
hemoglobin and hematocrit levels
Timepoint
Hemoglobin and hematocrit levels will be monitored before and 12-24 hours after delivery.
Method of measurement
hemoglobin and hematocrit are measured by blood test.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Women in the study group, received one gram intravenous TA, 10 min before skin incision in 200 mL normal saline over 10 min. In this study, TA was supplied in 2 × 500 mg/ mL ampoules obtained from kharazmi Pharmaceutical Company in Iran.
Category
Treatment - Drugs

2

Description
Control group: Women in the control group, received 10mL placebo (distilled water) 10 min before skin incision in 200 mL normal saline over 10 min. The placebo comprised 2×5 ml distilled water ampoules from Shahid Ghazi Pharmaceutical Company in Tabriz - Iran.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Izadi hospital
Full name of responsible person
Esmat Jafarbegloo
Street address
Azar street
City
Qom
Province
Ghoum
Postal code
3715835155
Phone
+98 25 3783 1371
Email
jafarbegloo_2004@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Doctor Ehsan sharifi
Street address
saheli street
City
Qom
Province
Ghoum
Postal code
3715835155
Phone
+98 25 3783 1371
Email
jafarbegloo_2004@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum University of Medical Sciences
Proportion provided by this source
1
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
Ghoum University of Medical Sciences
Full name of responsible person
Esmat Jafarbegloo
Position
Instructor. faculty member
Latest degree
Master
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No 2. East moallem, moallem Blvd, Qom
City
Qom
Province
Ghoum
Postal code
3715835155
Phone
+98 25 3783 1371
Email
jafarbegloo_2004@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Esmat Jafarbegloo
Position
Instructor Faculty member
Latest degree
Master
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No2. East moallem. moallem Blvd. Qom.
City
Qom
Province
Ghoum
Postal code
3715835155
Phone
+98 25 3783 1371
Email
jafarbegloo_2004@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Esmat Jafarbegloo
Position
instructor faculty member
Latest degree
Master
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No2. East moallem. moallem Blvd. Qom.
City
Qom
Province
Ghoum
Postal code
3715835155
Phone
+98 25 3783 1371
Email
jafarbegloo_2004@yahoo.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All of the above are documented and can be sent via email.
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Researchers working in scientific institutes
Under which criteria data/document could be used
Scientific uses to continue the work process or aggregate data
From where data/document is obtainable
To the researcher email
What processes are involved for a request to access data/document
Refer a reputable scientific institution to the applicant via email
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