Effect of tranexamic acid on postpartum hemorrhage of natural delivery in Shariati hospital (2014-15):
Purpose of the study: this research aimed to investigate the effect of tranexamic acid on postpartum blood loss through natural delivery in Shariati hospital (2014-15).
Design: the research population consisted of all pregnant women visiting shariati instructional hospital in bandar abbass who opted for a natural delivery. The treatment group and the control in the sample each consisted of 120 participants. This randomized clinical trial was controlled and double-blinded. Methods: The present case-control research explored the effect of intravenous tranexamic acid (1g). Therefore, 1 g of the acid (in 200 mL of normal saline) was given to the treatment group while the control received a placebo (destilled water in 200 mL of normal saline). Immediately after the emergence of placenta, both groups received 20 units of oxytocin solved in 500 mL of normal saline in 20 minutes. Blood sample tests were taken from the participants once 1-12 hours prior to the childbirth and once again 12-24 hours afterwards to measure hemoglobin and hematocrite. The inclusion criteria were pregnancy with a singleton, pregnancy age of 38-42 weeks, mother's age of 18-35 years and finally 5 years or less experience of pregnancy and normal blood pressure. The exclusion criteria were excessively long (over13 hours) induction duration in the first phase of delivery, experience of prior c-section or uterine surgery, uterine fibroma, history of internal diseases such as cardiovascular or renal problems. The primary variable was the effect of trabexamic acid on natural delivery hemorrhage. The secondary variable was natural delivery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017052029485N3
Registration date:2017-05-27, 1396/03/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-27, 1396/03/06
Registrant information
Name
Ali Safari
Name of organization / entity
School of public health, Shahid beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 3275 5043
Email address
alisafari_31@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Hormozgan University of Medical Sciences
Expected recruitment start date
2016-01-04, 1394/10/14
Expected recruitment end date
2016-04-24, 1395/02/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of tranexamic acid on postpartum hemorrhage of natural delivery in Shariati hospital (2014-15):
Public title
Effect of tranexamic acid on postpartum hemorrhage of natural delivery in Shariati hospital (2014-15):
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria were pregnancy with a singleton, pregnancy age of 38-42 weeks, mother's age of 18-35 years and finally 5 years or less experience of pregnancy and normal blood pressure. The exclusion criteria were excessively long (over13 hours) induction duration in the first phase of delivery, experience of prior c-section or uterine surgery, uterine fibroma, history of internal diseases such as cardiovascular or renal problems.
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:
240
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
Ethics committee of Hormozgan University of Medical Sciences
Street address
ice chancellor for research and technology, Shahid Mohamadi Hospital
City
Bandar Abbas
Postal code
7914964157
Approval date
2015-11-23, 1394/09/02
Ethics committee reference number
HUMS.REC.1394.92
Health conditions studied
1
Description of health condition studied
delivery
ICD-10 code
o72
ICD-10 code description
postpartum haemorrhage
Primary outcomes
1
Description
Average hemorrhage
Timepoint
12-24 hours after delivery
Method of measurement
Blood samples to measure hemoglobin and hematocrit
Secondary outcomes
empty
Intervention groups
1
Description
To the control group was injected took placebo tranexamic acid (distilled water) in 200 ml of normal saline
Category
Treatment - Drugs
2
Description
To the intervention group received 1 g of tranexamic acid in 200 ml intravenous saline injections.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital Dr. Ali Shariati
Full name of responsible person
Azin alavi
Street address
Bandar Abbas, hospital, doctor Ali Shariati, Shahid Nasser Blvd.
City
Bandar Abbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Hormozgan University of Medical Sciences
Full name of responsible person
Teamour aghamolaei
Street address
Vice Chancellor for research of Hormozgan University of Medical Sciences
City
Bandar abbas
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 of 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
Hospital Dr. Ali Shariati
Full name of responsible person
Zinab Nasiri
Position
Resident of Obstetrics and Gynecology.
Other areas of specialty/work
Street address
Hospital Dr. Ali Shariati
City
Bandar Abbas
Postal code
Phone
+98 917 769 0672
Fax
Email
nasiri@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dr.Shariati hospital
Full name of responsible person
Azin Alavi
Position
Assistant Professor
Other areas of specialty/work
Street address
Bandar abbas
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
Hospital Dr. Ali Shariati
Full name of responsible person
Zinab Nasiri
Position
Resident of Obstetrics and Gynecology.
Other areas of specialty/work
Street address
Bandar Abbas, Ali Shariati hospital, Shahid Nasser Blvd.
City
Bandar Abbas
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)