Effect of oral and intravenous Tranexamic Acid for preventing postpartum hemorrhage after cesarean delivery
Design
A clinical trial with the control group, randomized, single-center trial, Sample size of 100 people.
Settings and conduct
Amir Al-Momenin Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18 and 40 years; Candidate for a non-emergency cesarean section; A singleton pregnancy with a gestational age between 38 and 39 weeks that has been confirmed by ultrasound.
Exclusion Criteria: Preeclampsia, premature birth, prolonged rupture of the water sac, multiple births; Visualization of fetal anomalies by ultrasound; Previous history of systemic diseases.
Intervention groups
Intervention group: In this group, according to the protocol, the infusion of one gram of tranexamic acid (two 500 mg TRANEXIP® ampoules manufactured by Caspian Pharmaceutical Company, Iran) in 200 ml of normal saline serum will be done within 10 minutes before on start the operation.
Control group: In this group, according to the protocol, 2 grams of oral tranexamic acid (8 capsules of 250 mg TRANCID® manufactured by Amin Pharmaceutical Company of Iran) will be given to the patient one hour before the operation.
Main outcome variables
Blood pressure; Postpartum bleeding volume.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N78
Registration date:2023-07-06, 1402/04/15
Registration timing:prospective
Last update:2023-07-06, 1402/04/15
Update count:0
Registration date
2023-07-06, 1402/04/15
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-11, 1402/04/20
Expected recruitment end date
2025-03-18, 1403/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral and intravenous Tranexamic Acid for preventing postpartum hemorrhage after cesarean delivery
Public title
Effect of oral and intravenous Tranexamic Acid for preventing postpartum hemorrhage after cesarean delivery
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 40 years
Candidate for non-emergency cesarean section
A singleton pregnancy with a gestational age between 38 and 39 weeks that has been confirmed by ultrasound
Exclusion criteria:
Preeclampsia, premature birth, prolonged rupture of the water sac, multiple births
Visualization of fetal anomalies by ultrasound
Previous history of systemic diseases
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization; Individual; Random Number Tables.
Randomized permutation blocks (block 2).
Using Excel software to generate random number tables
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient and the midwife who distributes the drugs among the patients will be unaware of the prescribed drug for each patient
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2023-05-22, 1402/03/01
Ethics committee reference number
IR.SEMUMS.REC.1402.038
Health conditions studied
1
Description of health condition studied
Hemorrhage after cesarean delivery
ICD-10 code
O34.21
ICD-10 code description
Maternal care for scar from previous cesarean delivery
Primary outcomes
1
Description
Blood pressure
Timepoint
Before the start of cesarean section and 2 hours after surgery
Method of measurement
Heart monitor device
2
Description
Postpartum bleeding volume
Timepoint
The difference in the weight of sheets, gauze and long gauze used during surgery and up to 2 hours after surgery
Method of measurement
"Mahek" brand digital scale (made in Iran with an accuracy of 0.1 gr)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, according to the protocol, the infusion of one gram of tranexamic acid (two 500 mg TRANEXIP® ampoules manufactured by Caspian Pharmaceutical Company, Iran) in 200 ml of normal saline serum will be done within 10 minutes before on staret the operation.
Category
Treatment - Drugs
2
Description
Control group: In this group, according to the protocol, 2 grams of oral tranexamic acid (8 capsules of 250 mg TRANCID® manufactured by Amin Pharmaceutical Company of Iran) will be given to the patient one hour before the operation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Al-Momenin Hospital
Full name of responsible person
Satinik Darzi
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
Sati.darzi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Ehsani
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
fatemehehsani59@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Sati Nik Darzi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
Sati.darzi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Sati Nik Darzi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
Sati.darzi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Sati Nik Darzi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
Sati.darzi@gmail.com
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