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The effect of intravenous tranexamic acid on blood loss after vaginal delivery: A Randomized Controlled Trial

Protocol summary

Summary
This study is triple blind randomized controlled trial that will be carried out on 120 pregnant women. Subjects will be enrolled by using convenience sampling and randomly divided into two groups of 60 patients. After delivery of the anterior shoulder, subjects in the intervention group will receive 1g intravenous tranexamic acid in 200 ml normal saline over10 minutes and the control group will receive 1g placebo. For measuring estimated blood loss, Blood collection container will be placed under the patient's bed. Also a plastic cover and drape will be spread under parturient woman immediately after neonate delivery. Differences between the weight of the full and empty container and the dry and bloody plastic cover, drapes and quaze pads will be recorded during the first two hours after delivery. Estimated blood loss will be measured by the method of Gai et al. Following delivery of the placenta, 10 units of oxytocin in 500 mL of normal saline will be infused intravenously to both groups and the duration of the third stage of labor, neonate and placental weight will be recorded. Complications resulting from injection of tranexamic acid and vital signs will be monitored during the first two hours after delivery. Before and 12-24 hours after delivery, the level of hemoglobin and hematocrit of subjects will be measured. Calculated blood loss will be assessed according to pre- and post delivery hematocrit. SPSS software will be used for data analysis and independent t-test, ANCOVA, Ki-square test will be used. Following delivery of the placenta, 10 units of oxytocin in 500 mL of normal saline will be infused intravenously to both groups and the duration of the third stage of labor, neonate and placental weight will be recorded. Complications resulting from injection of tranexamic acid and vital signs will be monitored during the first two hours after delivery. Before and 12-24 hours after delivery, the level of hemoglobin and hematocrit of subjects will be measured. Calculated blood loss will be assessed according to pre- and post delivery hematocrit. SPSS software will be used for data analysis and independent t-test, ANCOVA, Ki-square test will be used.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012072910324N2
Registration date: 2012-08-09, 1391/05/19
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-08-09, 1391/05/19
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Women's Reproductive Health Research Center, Tabriz University of Medical Sciences
Expected recruitment start date
2012-08-15, 1391/05/25
Expected recruitment end date
2012-10-30, 1391/08/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intravenous tranexamic acid on blood loss after vaginal delivery: A Randomized Controlled Trial
Public title
The effect of intravenous tranexamic acid on blood loss after vaginal delivery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: -Women with singleton pregnancy between 38 to 42 weeks - Cephalic presentation - No history of cesarean section or uterine surgery - No history of uterine myoma - Normal blood pressure - No history of postpartum haemorrhage - No history of coagulation disorders - No history of heart disease - No history of renal disease - No history of blood disorders and anemia - No history of cerebrovascular disease - Absence of diabetes and preeclampsia in pregnancy current - Absence of polyhydramnious of macrosomia in the current pregnancy - lack of long-term induction of labor in first stage Exclusion criteria: - Instrumental delivery - Extensive vaginal and cervical lacerations - Need for placenta curettag - Continuous pressure in the fundus of the uterus before the fetus and placenta expulsion.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
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
Tabriz University of Medical Sciences Ethics Committee
Street address
Tabriz-Golgasht street-Tabriz University of Medical Sciences-Building 2 - Floor 3
City
Tabriz
Postal code
Approval date
2012-06-13, 1391/03/24
Ethics committee reference number
9168

Health conditions studied

1

Description of health condition studied
postpartum haemorrhage
ICD-10 code
O72.1
ICD-10 code description
Other immediate postpartum haemorrhage

Primary outcomes

1

Description
comparison of measured blood loss after delivery in the intervention group (receiving tranexamic acid and oxytocin) and control group ( receiving placebo of tranexamic acid and oxytocin)
Timepoint
first two hours after delivery
Method of measurement
Differences between the weight of the full and empty container and the dry and bloody plastic cover, drapes and quaze pads will be recorded during the first two hours after delivery and blood loss will be assessed by the method of Gai et al.

2

Description
Comparison of the calculated blood loss after delivery in the intervention group (receiving tranexamic acid and oxytocin) and control group ( receiving placebo tranexamic acid and oxytocin)
Timepoint
Before and 12-24 hours after delivery
Method of measurement
Calculated blood loss will be assessed according to pre- and post delivery hematocrit

Secondary outcomes

1

Description
Comparison of postdelivery hematocrit with effect control of predelivery hematocrit between intervention group(receiving tranexamic acid and oxytocin) and control group (receiving placebo of tranexamic acid and oxytocin)
Timepoint
Before and 12-24 hours after delivery
Method of measurement
hematocrit assessment

2

Description
Comparison of postdelivery Hemoglobin with effect control of predelivery Hemoglobin between intervention group (receiving tranexamic acid and oxytocin) and control group (receiving placebo of tranexamic acid and oxytocin)
Timepoint
Before and 12-24 hours after delivery
Method of measurement
Hemoglobin assessment

3

Description
Comparison of the mean duration of the third stage of labor between intervention group (receiving tranexamic acid and oxytocin) and control group (receiving placebo of tranexamic acid and oxytocin)
Timepoint
From newborn delivery to exclusion of the placenta
Method of measurement
Check of the time in second

4

Description
Comparsion of need for additional uterotonic medication after delivery between intervention group (receiving tranexamic acid and oxytocin) and control group (receiving placebo of tranexamic acid and oxytocin)
Timepoint
30, 45, 60, 90 and 120 minute after delivery
Method of measurement
Checklist

5

Description
Comparison of vital signs between intervention group (receiving tranexamic acid and oxytocin) and control group (receiving placebo of tranexamic acid and oxytocin)
Timepoint
15-30-45-60-90 and 120minutes after delivery
Method of measurement
cheklist

Intervention groups

1

Description
Intervention group: After delivery of anterior shoulder, 1g tranexamic acid in 200 ml normal saline will be infused intravenously over 10 minutes.
Category
Treatment - Drugs

2

Description
Control group: After delivery of anterior shoulder, 1g placebo of tranexamic acid in 200 ml normal saline will be infused intravenously over 10 minutes.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Educational and Treatment Center, Tabriz
Full name of responsible person
Mina shirdel
Street address
Tabriz-South Artesh street, Alzahra Educational and Treatment Center
City
Tabriz

2

Recruitment center
Name of recruitment center
Taleghany Educational and Treatment Center, Tabriz
Full name of responsible person
Mina Shirdel
Street address
Tabriz, Rah Ahan street
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Womens Reproductive Health Research center, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Abasalizade
Street address
South Artesh Ave., Alzahra educational and treatment center
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Womens Reproductive Health Research center, Tabriz 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
Tabriz University of Medical Sciences, Nursing & Midwifery Faculty
Full name of responsible person
Dr.Mojgan Mirghafourvand
Position
PhD of Reproductive Health/ Assistant Professor
Other areas of specialty/work
Street address
Tabriz Nursing & midwifery Faculty , South Shariaty
City
Tabriz
Postal code
51745-347
Phone
+98 41 1479 6770
Fax
+98 47 96969
Email
Mirghafourvandm@tbzmed.ac.ir, Mirg1385@yahoo.com
Web page address
http://nursing.tbzmed.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences, Nursing & Midwifery Faculty
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
PhD of Reproductive Health/ Assistant Professor
Other areas of specialty/work
Street address
Tabriz Nursing & midwifery Faculty , South Shariaty
City
Tabriz
Postal code
51745-347
Phone
+98 41 1479 6770
Fax
+98 47 96969
Email
Mirghafourvandm@tbzmed.ac.ir
Web page address
http://nursing.tbzmed.ac.ir

Person responsible for updating data

Contact

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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