Protocol summary

Summary
The present randomized, double blind clinical experiment was carried out in 2013-14 at Shariati Hospital of Bandar Abbas, Iran. Two hundred pregnant women who visited this hospital and volunteered to have a cesarean surgery participated in this research. All women between 20 to 40 years of age who were in their 37th to 40th week of pregnancy and had opted for a cesarean surgery entered the study. The following were excluded: those with an experience of twinning; placenta abnormalities; severe pre-eclampsia; macrosomy; polyhydramnios; previous cesarean or abdominal surgeries; kidney, brain, blood or liver disorders; coagulopathy; anemia; thrombophilia; thromboembolic disorders; allergy to Tranexamic acid. In addition, patients whose BMI was higher than 30 were excluded from the study. At the outset, all patients would get the required and adequate information about this research, and can only enter the study with full consent. On entering the research, patients equally divided into two groups following a blocked randomization. In the intervention group, with the help of an anesthesiologist, 20 minutes before the cesarean surgery 10 milligrams of Tranexamic acid for each kilogram of body mass combined with 200 milliliters of normal saline slowly injected within 5 minutes. Patients in the control group received only 200 milliliters of normal saline within 5 minutes. Neither the patient nor the researcher would be informed of the type of group. After the surgery all patients received 10 units of Tranexamic acid injected along with 500 milliliters of normal saline within 20 minutes. Moreover, all patients also received 30 units of oxytocin within the first 8 hours of the surgery. In the case of atonic uterus, 10 more units of oxytocin infusion added. Weight of blood gases and surgical sheets before and after use recorded. It needs to be reminded that amniotic fluid and the blood emerged due to skin incision and abdominal layers would be gathered in another suction and did not enter our estimations. The amount of the blood lost estimated 2 hours after the delivery (based on the difference of the weight of the tampon used). At the outset of the surgery, a tampon was inserted into the vagina, the difference of its weight before the surgery and 2 hours after the surgery was calculated. Therefore, the amount of bleeding is estimated. Hb was checked 24 hours after the cesarean surgery. In case, the level of hemoglobin is lower than 8, blood transfusion was done.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014100419396N1
Registration date: 2015-02-09, 1393/11/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-02-09, 1393/11/20
Registrant information
Name
Razieh Rrajabzadeh
Name of organization / entity
Hormozgan University of Medical Scienes
Country
Iran (Islamic Republic of)
Phone
+98 76 3333 7104
Email address
barvari@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Hormozgan University of Medical Sciences
Expected recruitment start date
2013-04-22, 1392/02/02
Expected recruitment end date
2013-06-27, 1392/04/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of Tranexamic acid in blood loss during and after cesarean section
Public title
effectiveness of Tranexamic acid in blood loss during and after cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
All women between 20 to 40 years of age who were in their 37th to 40th week of pregnancy and had opted for a cesarean surgery entered the study. The following were excluded: those with an experience of twinning; placenta abnormalities; severe pre-eclampsia; macrosomy; polyhydramnios; previous cesarean or abdominal surgeries; kidney, brain, blood or liver disorders, coagulopathy; anemia; thrombophilia; thromboembolic disorders; allergy to Tranexamic acid. In addition, patients whose BMI was higher than 30 were excluded from the study.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Hormozgan University of Medical Sciences
Street address
vice chancellor for research and technology, Shahid Mohamadi Hospital
City
Bandar Abbas
Postal code
Approval date
2013-05-08, 1392/02/18
Ethics committee reference number
90-92/149

Health conditions studied

1

Description of health condition studied
caesarean section
ICD-10 code
82
ICD-10 code description
Single delivery by caesarean section

Primary outcomes

1

Description
The amount of the blood loss
Timepoint
The amount of the blood lost would be estimated 2 hours after the delivery (based on the difference of the weight of the tampon used). At the outset of the surgery, a tampon would be inserted into the vagina, the difference of its weight before the surgery and 2 hours after the surgery will be calculated.
Method of measurement
The amount of blood loss would be estimated through Gai et al.’s method:

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group, with the help of an anesthesiologist, 20 minutes before the cesarean surgery 10 milligrams of Tranexamic acid for each kilogram of body mass combined with 200 milliliters of normal saline will be slowly injected within 5 minutes
Category
Treatment - Drugs

2

Description
Patients in the control group, will receive only 200 milliliters of normal saline within 5 minutes
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospital Dr. Ali Shariati
Full name of responsible person
Dr. Azin Alavi
Street address
City
Bandar Abbas

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Dr. Azim Nejatizadeh
Street address
Hormozgan University of Medical Sciences-Research Council.
City
Bandar Abbas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hormozgan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shariati Hospital, Hormozgan University of Medical Sciences
Full name of responsible person
Azin Alavi
Position
Assistant Professor
Other areas of specialty/work
Street address
Shariati Hospital, Hormozgan University of Medical Sciences
City
Bandar Abbas
Postal code
Phone
+98 76 3333 2424
Fax
Email
azin_alavi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shariati hospital, Hormozgan University of Medical Sciences
Full name of responsible person
Azin Alavi
Position
Assistant Professor
Other areas of specialty/work
Street address
Shariati hospital, Hormozgan University of Medical Sciences
City
Bandar Abbas
Postal code
Phone
+98 76 3333 2424
Fax
Email
azin_alavi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shariati hospital, Hormozgan University of Medical Sciences
Full name of responsible person
Dr. Sara Moshfeghi
Position
Assistant Professor of Obstetrics and Gynecology.
Other areas of specialty/work
Street address
Shariati hospital, Hormozgan University of Medical Sciences
City
Bandar Abbas
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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