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The role of tranexamic acid in management of uterine atony during delivery

Protocol summary

Summary
In this randomized clinical trial study, we investigated the effect of tranexamic acid in 90 patients,who were diagnosed as uterine atony by obstetrician following delivery(cesarean or vaginal) over 6 months period. The patients randomly allocated into two equal groups. In group1(n=45) received traditional treatment including oxytocin(30 IU oxytocin in 1 litr.normal saline),metergine (0.2 mg IM),uterine massage,ice application ,in group 2(n=45),the patients received a single dose tranexamic acid(1gr),in 100 cc DW5%, IV,over 10 min.,in addition to traditional treatment. The amount of blood loss, hemoglobin changes , need for surgical intervention, the need for blood products, duration of hospitalization, the two groups were compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013052613473N1
Registration date: 2013-07-14, 1392/04/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-07-14, 1392/04/23
Registrant information
Name
Zoya Sadeghipour
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1223 6374
Email address
zsadeghipour@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
instution
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The role of tranexamic acid in management of uterine atony during delivery
Public title
Tranexamic acid for treatment of postpartum hemorrhage
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:all women who were diagnosed as uterine atony by obstetrician following delivery; exclusion criteria:history of any heart disease;liverdisease;kidney disease;history of any hematologic or Thrombophlebitis disease; Thromboembolism disease ;and all women who resieved general anesthesia during delivery.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
"Qazvin University of Medical Science "
Street address
shahid bahonar bulvar
City
Qazvin
Postal code
Approval date
2013-05-27, 1392/03/06
Ethics committee reference number
28/20/7390

Health conditions studied

1

Description of health condition studied
Uterine atony
ICD-10 code
O62.2
ICD-10 code description
Other uterine inertia

Primary outcomes

1

Description
The need for surgical intervention.
Timepoint
Immediately after the intervention until discharge
Method of measurement
need to hypogastric Artery ligation, uterine artery ligation and hysterectomy based on Surgeon's visual judgment

2

Description
Bleeding volume after Atony
Timepoint
Immediatly after Atony
Method of measurement
Per cc and counts gazes and long gazes,and the volume of blood in suction

3

Description
Hemoglobin's changes
Timepoint
6 and 24 hours after bleeding
Method of measurement
gr/dl with Spectrophotometer calibrated

4

Description
The need for blood products
Timepoint
After intervention until discharge
Method of measurement
based on unit and signs in surgen's examination or Hemoglobin less than 7

5

Description
Hospitalization
Timepoint
after delivery until discharge
Method of measurement
day

Secondary outcomes

1

Description
nousa/vomiting/thromoamboli
Timepoint
after delivery until release
Method of measurement
examination

Intervention groups

1

Description
In the intervention group after uterine Atony, in addition to receiving 30 units of oxytocin within 1 Liter saline,02mg. Methergine IM , uterine massage and ice packs, 1gr trans examic acid,in the 100 cc 5% dextrose infusion within 10 minutes .
Category
Treatment - Drugs

2

Description
In control group,after uterine Atony only would recevied (30 IU oxytocin in 1 liter of normal saline solution 0.2 mg IM ampoule Methergine and uterine massage and ice packs) .
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kosar hospital
Full name of responsible person
zoya sadeghipour.MD
Street address
taleghani street
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
"Qazvin University of Medical Sciences"
Full name of responsible person
Mr Reza Ahmadian
Street address
shahid bahonar bulvar
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
"Qazvin 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
Qazvin medical universiyi
Full name of responsible person
Zoya sadeghipour
Position
Residence of gynecology
Other areas of specialty/work
Street address
Kosar hospital-taleghani street
City
Qazvin
Postal code
Phone
+98 28 1223 6374
Fax
Email
zoya7s@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin medical university
Full name of responsible person
dr.Zoya sadeghipour
Position
residence of gynecology
Other areas of specialty/work
Street address
Kosar hospital-taleghani street
City
Tehran
Postal code
Phone
+98 21 4424 8439
Fax
Email
zoya7s@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qazvin medical university
Full name of responsible person
Ezat hajseid javadi
Position
gynecologist
Other areas of specialty/work
Street address
KOsar hospital-taleghani street
City
Qazvin
Postal code
Phone
+98 28 1223 6374
Fax
Email
Dr_seidjavadi@yahoo.com
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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