To assess the efficacy of Tranexamic acid in reducing hemorrhage after vaginal delivery, a randomized, placebo- controlled clinical trial of 200 women with term, singleton pregnancy candidate for the first normal vaginal delivery is designed. Other inclusion criteria are no history of severe medical complications, thrombotic events, allergy to tranexamic acid, preeclampsia and visual problem. Exclusion criteria are patient avoidance and placenta abruption. Patients will be randomized with Block randomization method into two groups, after approval and inclusion criteria assessment. In the first group (experimental group) 1 gram of Tranexamic acid diluted in 20 ml dextrose 5% and in the second group (experimental group), 20 ml dextrose 5% and placebo(10 ml normal saline) will be administered soon after delivery. Hemoglobin level will be measured promptly at the time of admission and also 24 hours after delivery. The primary outcome is hemoglobin decline more than 10% (considered as postpartum hemorrhage). Blood pressure and pulse rate will be checked 1 hour and 2 hours after delivery. The studied parturient will be evaluated 24 hours after delivery in terms of drug induced complications and thrombotic events. Maternal outcomes such as need to transfusion, surgery, hysterectomy and death will be documented .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204079399N1
Registration date:2012-11-15, 1391/08/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-11-15, 1391/08/25
Registrant information
Name
Fereshteh Heidari Shirazi
Name of organization / entity
kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 2999
Email address
heidarifereshteh@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2012-11-10, 1391/08/20
Expected recruitment end date
2013-01-09, 1391/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A placebo-controlled clinical trial to assess efficacy of tranexamic acid in reducing hemorrhage after vaginal delivery
Public title
A placebo-controlled clinical trial to assess efficacy of tranexamic acid in reducing hemorrhage after vaginal delivery
Purpose
Prevention
Inclusion/Exclusion criteria
1- inclusion criteria:
- women with term, singleton pregnancy candidate for the first vaginal delivery
-No history of sever medical complications involving the heart,brain ,kidney
- No history of allergy to tranexamic acid
-No history of visual problem
-No history of sever pregnancy complications such as preeclampsia
-No history of thromboembolic events
2- exclusion criteria:
-patient avoidance
-placenta abruption
Age
From 15 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences 5th km of ghotberavandi blvd. Kashan Iran
City
Kashan
Postal code
87155/111
Approval date
2012-01-30, 1390/11/10
Ethics committee reference number
29/5/1/3603/پ
Health conditions studied
1
Description of health condition studied
postpartum hemorrhage
ICD-10 code
072.1
ICD-10 code description
Haemorrhage following delivery of placenta
Primary outcomes
1
Description
hemoglobin
Timepoint
Before and 24 hours after delivery
Method of measurement
laboratory
2
Description
maternal death
Timepoint
During 24 hours after delivery
Method of measurement
outcome form
Secondary outcomes
1
Description
Blood transfusion
Timepoint
24 hours after delivery
Method of measurement
outcome form
2
Description
thromboembolic events in mother
Timepoint
24 hours after delivery
Method of measurement
physical exam
3
Description
Surgical intervention
Timepoint
24 hours after delivery
Method of measurement
outcome form
Intervention groups
1
Description
In the experimental group , 1gram of tranexamic acid diluted in 20ml Dextrose 5% will be administered intravenously soon after neonatal delivery. Blood pressure, pulse rate will be checked, 1 hour and 2 hours after delivery. Hemoglobin levels will be measured promptly at the time of admission and also 24 hours after delivery.The studied parturients will be evaluated 24 hours after normal vaginal delivery in terms of drug induced complications . Maternal outcomes such as need to transfusion , surgery ,hysterectomy or death if occur will be documented .
Category
Prevention
2
Description
In the control group , 20ml Dextrose 5% and placebo(normal saline) will be administered intravenously soon after neonatal delivery. Blood pressure, pulse rate will be checked, 1 hour and 2 hours after delivery.Hemoglobin levels will be measured promptly at the time of admission and also 24 hours after delivery. The studied parturients will be evaluated 24 hours after normal vaginal delivery in terms of drug induced complications . Maternal outcomes such as need to transfusion , surgery ,hysterectomy or death if occur will be documented .
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr.Fereshteh Heidari Shirazi
Street address
Shahid Beheshti Hospital 5th km of Ghotberavandi blvd. Kashan Iran
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research ,Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholamali Hamidi
Street address
Kashan University of Medical Sciences 5th km of Ghotberavandi blvd. kashan iran
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research ,Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Dr.Fereshteh Heidari Shirazi
Position
Member of research committee
Other areas of specialty/work
Street address
Kashan University of Medical Sciences 5th km of Ghotberavandi blvd. Kashan Iran
City
Kashan
Postal code
87159/88141
Phone
+98 36 1555 0021
Fax
+98 36 1557 5057
Email
heidarifereshteh@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr.Mansureh Samimi
Position
Gynecologist
Other areas of specialty/work
Street address
Shahid Beheshti Hospital 5th km of Ghotberavandi blvd. Kashan Iran
City
Kashan
Postal code
87159/88141
Phone
+98 36 1555 0021
Fax
+98 36 1557 5057
Email
m_samimi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr.Fereshteh Heidari Shirazi
Position
Research committee member
Other areas of specialty/work
Street address
Kashan University of Medical Sciences 5th km of Ghotberavandi blvd. Kashan Iran
City
kashan
Postal code
87159/88141
Phone
+98 36 1555 0021
Fax
+98 36 1557 5057
Email
heidarifereshte@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)