The purpose of this study was evaluation the prophylactic effect of tranexamic acid in blood loss during and after cesarean section.
Primiparas and multiparas females with singleton pregnancy during the gestational ages of 37 to 40 weeks who are going to be delivered by cesarean section through Pfannenstiel’s incision and spinal anesthesia are enrolled to the study. Patients with problem of heart, liver, kidney, hematologic or rheumatologic problems, history of thyroid disease, abnormal placental, severe preeclampsia, macrosomia, severe anemia and problematic obstetric history are not enrolled to the study.
Patients who have allergy to Tranexamic acid are excluding from study.
Patients are randomly placed in two groups equally. First group is receiving 1g intra venous tranexamic acid diluted with 20cc dextrose water 5% in operation room 15min before skin incision. Second group is receiving distilled water as placebo like this method. Total blood loss during the surgery and two hours later were measured through the amount of blood in suction machine and the weight of bloody pads, gauze and cloths. Variables include the effect of tranexamic acid on reducing blood loss during and after cesarean section, the need for blood transfusion, hysterectomy and evaluation of drug’s side effects in mothers.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201405313485N4
Registration date:2014-09-09, 1393/06/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-09, 1393/06/18
Registrant information
Name
Forozan Milani
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1722 9328
Email address
milani@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of tranexamic acid on blood loss during and after cesarean in women who candidate for cesarean section delivery by clinical trial study
Public title
The effect of tranexamic acid on blood loss during and after cesarean in women who candidate for cesarean section delivery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Primiparas and multiparas females with singleton pregnancy during the gestational ages of 37 to 40 weeks who are going to be delivered by cesarean section through fannenstiel’s incision and spinal anesthesia
Non-inclusion criteria: Patients with problem of heart, liver and kidney; hematologic or rheumatologic problems; history of thyroid disease; abnormal placental; severe preeclampsia; macrosomia; severe anemia; problematic obstetric history
Exclusion criteria: allergy to Tranexamic acid
Age
From 135 years old to 137 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Vice Chancellor for Research, Guilan University of Medical Sciences
Street address
Vice Chancellor for Research, Namjoo Street
City
Rasht
Postal code
Approval date
2014-08-19, 1393/05/28
Ethics committee reference number
1930231608
Health conditions studied
1
Description of health condition studied
Labour and delivery complicated by intrapartum haemorrhage, not elsewhere classified
ICD-10 code
0.72
ICD-10 code description
postpatrum-haemorrhage
Primary outcomes
1
Description
Blood loss during and two hours after surgery
Timepoint
During surgery until two hours
Method of measurement
Measuring the weight of bloody gauzes, pads and cloths during and two hours after the surgery and the amount of blood from the suction machine during the surgery
Secondary outcomes
1
Description
The need of blood transfusion
Timepoint
To 48 hours after a cesarean section
Method of measurement
Checking of hemoglobin and hematocrit during 12 to 24 hours after the surgery and checking vital signs every 4 hours
2
Description
The need of hysterectomy
Timepoint
To 48 hours after a cesarean section
Method of measurement
Checking vital signs and examination for Atonic uterus and abnormal vaginal bleeding every 4 hours
Intervention groups
1
Description
Giving 1g intra venous tranexamic acid diluted with 20cc dextrose water 5% in 15min before skin incision
Category
Treatment - Drugs
2
Description
Giving 1g intravenous distilled water as placebo diluted with 20cc dextrose water 5% in 15min before skin incision
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Dr. Roya Faraji
Street address
Alzahra hospital, Namjoo street
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Guilan University of Medical Sciences, Rasht, Iran
Full name of responsible person
Dr. Abtin Heidarzadeh
Street address
Vice Chancellor for Research, Guilan University of Medical Sciences, Namjoo street
City
Rasht
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, Guilan University of Medical Sciences, Rasht, Iran
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
Guilan University of Medical Sciences
Full name of responsible person
Dr. Forozan Milani
Position
Assistant Professor of Obstertics and Gynecolgy of Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Reproductive Health Research Center, Alzahra hospital, Namjoo street
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
forozanmilani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr. Forozan Milani
Position
Assistant Professor of Obstertics and Gynecolgy of Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Reproductive Health Research Centre, Alzahra Hospital, Namjoo Street
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
forozanmilani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Dalil Heirati
Position
B.S of Midwifery
Other areas of specialty/work
Street address
Reproductive Health Research Center, Alzahra hospital, Namjoo street
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)