IRCT | A comparison between the effect of tranexamic acid and placebo on the amount of hemorrhage in women following vaginal delivery and its adverse effects.

Protocol summary

Study aim: Effects of tranexamic acid on the amount of hemorrhage following vaginal delivery.
Design: double-blind placebo controlled randomized clinical trial on 200 women after vaginal delivery in Akbarabadi Hospital in Tehran..
Settings and conduct: 200 women after vaginal delivery in Akbarabadi Hospital in Tehran..
Participants/Inclusion and exclusion criteria: women with a singleton pregnancy; gestational age between 37-42 weeks; normal blood pressure (< 140/90 mmHg) and informed consent for the study. Exclusion criteria: history of coagulopathy; pre-eclampsia; placental abruption; hypersensitivity to tranexamic acid; Body Mass Index(BMI) of more than 30; episiotomy and history of cardiac, hepatic, renal and neurologic disorders.
Intervention groups: Women in the intervention group received 10 mg/kg infusion of tranexamic acid in 100 mL normal saline and the control group received one vial of distilled water (as placebo) in 100 mL normal saline.
Main outcome variables: serum hemoglobin level; need of additional uterotonic agents; need of blood transfusion and surgery. Drug adverse effects were also evaluated in the two groups.

General information

Reason for update
Acronym: TXA and PPH
IRCT registration information: IRCT registration number: IRCT20091023002624N22

Registration date: 2017-12-20, 1396/09/29

Registration timing: retrospective

Last update: 2017-12-20, 1396/09/29

Update count: 0
Registration date: 2017-12-20, 1396/09/29

Registrant information: Name

Maryam Kashanian

Name of organization / entity

Iran University of Medical Sciences

Country

Iran (Islamic Republic of)

Phone

+98 21 7752 3487

Email address

maryamka@iums.ac.ir

Recruitment status: Recruitment complete
Funding source: Investigator.

Expected recruitment start date: 2016-03-05, 1394/12/15
Expected recruitment end date: 2017-06-09, 1396/03/19
Actual recruitment start date: 2016-04-03, 1395/01/15
Actual recruitment end date: 2017-04-21, 1396/02/01
Trial completion date: empty

Scientific title: A comparison between the effect of tranexamic acid and placebo on the amount of hemorrhage in women following vaginal delivery and its adverse effects.

Public title: Effect of tranexamic acid on postpartum hemorrhage.
Purpose: Prevention
Inclusion/Exclusion criteria: Inclusion criteria:

Pregnant singleton gestational age between 37-42 weeks normal blood pressure (< 140/90 mmHg) informed consent for the study

Exclusion criteria:

history of coagulopathy pre-eclampsia placental abruption hypersensitivity to tranexamic acid Body Mass Index(BMI) of more than 30 episiotomy history of cardiac, hepatic, renal and neurologic disorders
Age: From 18 years old to 45 years old
Gender: Female

Phase

2-3

Groups that have been masked

Participant
Care provider
Investigator
Outcome assessor
Data analyser

Sample size

Target sample size: 200

Actual sample size reached: 207

Randomization (investigator's opinion)

Randomized

Randomization description

simple, individual randomization using sealed envelops.

Blinding (investigator's opinion)

Triple blinded

Blinding description

Participants, investigator and care providers( midwife) were blinded to the study group.

Placebo

Used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Iran University of Medical Sciences

Street address

Hemmat highway, Chamran Cross.

City

Tehran

Province

Tehran

Postal code

1449614535
Approval date: 2016-04-27, 1395/02/08
Ethics committee reference number: IR.IUMS.FMD.REC 1395.9211900010

Health conditions studied

1

Description of health condition studied: hemorrhage following delivery
ICD-10 code: O72
ICD-10 code description: haemorrhage after delivery of fetus or infant

2

Description of health condition studied: hemorrhage following delivery
ICD-10 code: O72.0
ICD-10 code description: Third-stage haemorrhage

3

Description of health condition studied: hemorrhage following delivery
ICD-10 code: O75.9
ICD-10 code description: Complication of labour and delivery, unspecified

4

Description of health condition studied: complications after delivery.
ICD-10 code: O75.8
ICD-10 code description: Other specified complications of labour and delivery

5

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

Primary outcomes

1

Description: hemoglobin level.
Timepoint: At the time of admission and 6 hours after delivery .
Method of measurement: blood test

Secondary outcomes

1

Description: urine output
Timepoint: was checked at the beginning of labor and then during 6 hours after delivery ; every 15 minutes after labor for the first hour and then every 30 minutes for the second hour and finally every hour for another 4 hours.
Method of measurement: Data sheets, Monitoring of urine output

2

Description: respiratory rate
Timepoint: was checked at the beginning of labor and then during 6 hours after delivery ; every 15 minutes after labor for the first hour and then every 30 minutes for the second hour and finally every hour for another 4 hours.
Method of measurement: Data sheets, Monitoring of respiratory rate

3

Description: blood pressure
Timepoint: was checked at the beginning of labor and then during 6 hours after delivery ; every 15 minutes after labor for the first hour and then every 30 minutes for the second hour and finally every hour for another 4 hours.
Method of measurement: Data sheets, Monitoring of blood pressure

4

Description: pulse rate
Timepoint: was checked at the beginning of labor and then during 6 hours after delivery ; every 15 minutes after labor for the first hour and then every 30 minutes for the second hour and finally every hour for another 4 hours.
Method of measurement: Data sheets,Monitoring of pulse rate

5

Description: need of additional uterotonic agents .
Timepoint: Any time after delivery.
Method of measurement: Data sheets, using uterotonic agents.

6

Description: need of blood transfusion.
Timepoint: Any time after delivery up to 24 hours.
Method of measurement: blood transfusion

7

Description: need to surgical interventions.
Timepoint: Any time after delivery up to 24 hours.
Method of measurement: surgical interventions.

8

Description: side effects of Tranexamic acid.
Timepoint: Any time after delivery up to 42 days.
Method of measurement: Data sheets

Intervention groups

1

Description: Intervention group received 10 mg/kg intravenous TXA in 100 mL normal saline.
Category: Treatment - Drugs

2

Description: Control group received one vial of distilled water (as placebo) in 100 mL normal saline.
Category: Prevention

Recruitment centers

1

Recruitment center: Name of recruitment center

Akbarabadi Teaching Hospital

Full name of responsible person

Maryam Kashanian

Street address

Molavi avenue, Molavi Cross Road.

City

Tehran

Province

Tehran

Postal code

۱۱۶۸۷۴۳۵۱۴

Phone

+98 21 5563 3244

Email

maryamkashanian@yahoo.com

1

Sponsor: Name of organization / entity

Iran University of Medical Sciences

Full name of responsible person

Dr Seyed Ali Javad Mousavi

Street address

Hemmat High way, Junction of Chamran Highway.

City

Tehran

Province

Tehran

Postal code

1۴۴۹۶۱۴۵۳۵

Phone

+98 21 86701

Email

PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Iran 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

Iran University of Medical Sciences

Full name of responsible person

Maryam Kashanian

Position

Professor.

Latest degree

Specialist

Other areas of specialty/work

Street address

Molavi avenue, Molavi Cross Road.

City

Tehran

Province

Tehran

Postal code

۱۱۶۸۷۴۳۵۱۴

Phone

+98 21 5563 3244

Fax

Email

maryamkashanian@yahoo.com

Web page address

Person responsible for scientific inquiries

Contact: Name of organization / entity

Iran University of Medical Sciences

Full name of responsible person

Maryam Kashanian

Position

Professor

Latest degree

Specialist

Other areas of specialty/work

Gynecology and Obstetrics

Street address

Molavi avenue, Molavi Cross Road.

City

Tehran

Province

Tehran

Postal code

۱۱۶۸۷۴۳۵۱۴

Phone

+98 21 5563 3244

Fax

Email

maryamkashanian@yahoo.com

Web page address

Person responsible for updating data

Contact: Name of organization / entity

Iran University of Medical Sciences

Full name of responsible person

Maryam Kashanian

Position

Professor

Latest degree

Specialist

Other areas of specialty/work

Gynecology and Obstetrics

Street address

Molavi Avenue, Molavi Cross Road.

City

Tehran

Province

Tehran

Postal code

۱۱۶۸۷۴۳۵۱۴

Phone

+98 21 5563 3244

Fax

Email

maryamkashanian@yahoo.com

Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD): Undecided - It is not yet known if there will be a plan to make this available
Study Protocol: Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan: Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form: Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report: Undecided - It is not yet known if there will be a plan to make this available
Analytic Code: Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary: Undecided - It is not yet known if there will be a plan to make this available

A comparison between the effect of tranexamic acid and placebo on the amount of hemorrhage in women following vaginal delivery and its adverse effects.