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Efficacy and Safety of Prophylactic Use of Tranexamic Acid for Decreasing the Blood Loss in Elective Cesarean Section: A Placebo-Controlled Randomized Clinical Trial

Protocol summary

Study aim
Evaluation of e efficacy and safety of tranexamic acid in decreasing the bleeding in elective cesarean section
Design
A double-blind placebo-controlled randomized clinical trial
Settings and conduct
This study was conducted in a tertiary level teaching hospital. Included women were randomly allocated to 2 groups. In first group patients received 1 gram tranexamic acid intravenously just before skin incision. In control group patients received same volume of 5% dextrose as placebo. The volume of blood loss during and 6 hours after surgery were measured by weighting the drapes and sponges before and after use and adding the volume of blood in suction bottle. Volume of bleeding were compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: singleton pregnancies aged between 37 and 42 weeks of gestation Exclusion criteria: patients with Known allergy to TXA, history of thromboembolic or coagulative disorders, history of renal, cardiac or hepatic impairment, gestational or chronic hypertension/pre-eclampsia, placental disorders, polyhydramnios; patients who had received aspirin 1 week before surgery.
Intervention groups
Receiving 1 gram tranexamic acid as bolus just before skin incision
Main outcome variables
Primary outcome was decreased intra-operative and post-operative blood loss in elective CS. Secondary outcome was occurrence of minor or major adverse reactions of TXA (headaches, fatigue, abdominal pain, nausea, vomiting, diarrhea, seizures, anaphylaxis, visual disturbances, pulmonary embolism, deep vein thrombosis, myocardial infarction, cerebrovascular accidents. adverse neonatal outcome and labor complications like increased uterine contractions and placental separation were also considered as secondary outcomes.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180819040830N2
Registration date: 2020-04-29, 1399/02/10
Registration timing: retrospective

Last update: 2020-04-29, 1399/02/10
Update count: 0
Registration date
2020-04-29, 1399/02/10
Registrant information
Name
Zahra Naeiji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5506 2628
Email address
z.naeigi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-29, 1398/12/10
Expected recruitment end date
2020-03-29, 1399/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and Safety of Prophylactic Use of Tranexamic Acid for Decreasing the Blood Loss in Elective Cesarean Section: A Placebo-Controlled Randomized Clinical Trial
Public title
Tranexamic Acid for Decreasing the Blood Loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
singleton pregnant women elective cesarean section gestational age between 37 and 42 weeks
Exclusion criteria:
patients with Known allergy to TXA history of thromboembolic or coagulation disorders known history of renal, cardiac or hepatic impairment gestational or chronic hypertension/pre-eclampsia placental disorders polyhydramnios patients who had received aspirin 1 week before surgery
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
computer-generated blocks of 4, block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Patient and gynecologist who performed the cesarean section and research assistant who measured the bleeding volume were blinded to the intervention. research assistant who prepared the drug and placebo for administration were open to the intervention.
Placebo
Used
Assignment
Parallel
Other design features
--

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak,
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2018-11-03, 1397/08/12
Ethics committee reference number
IR.SBMU.RETECH.REC.1397.662

Health conditions studied

1

Description of health condition studied
peri-operative hemorrhage
ICD-10 code
O72.1
ICD-10 code description
Other immediate postpartum hemorrhage

Primary outcomes

1

Description
Intra-operative and post-operative blood loss in elective cesarean section
Timepoint
From skin incision to hours after surgery
Method of measurement
Intra-operative blood loss (from skin incision to skin closure) was measured by gravimetric method. Soaked drapes, mops, sponges, pads, and operation table perineal sheet were weighed with an electronic weighing scale before and after the surgery. The difference between their wet and dry weights was considered as the collected blood. Each mg of measured weight was considered as equivalent to 1 ml of blood. The total amount of blood loss (ml) was determined as the sum of blood absorbed by soaked mops, sponges, pads, drapes and perineal sheet plus blood collected in suction bottle after placental delivery (to exclude the measurement of amniotic fluid). Post-operative blood loss (first 6 hours after skin closure) was measured by weighing and numbering the vaginal pads used by the patient.

Secondary outcomes

1

Description
Occurrence of minor or major adverse reactions of tranexamic acid (headaches, fatigue, abdominal pain, nausea, vomiting, diarrhea, seizures, anaphylaxis, visual disturbances, pulmonary embolism, deep vein thrombosis, myocardial infarction, cerebrovascular accidents). adverse neonatal outcome and labor complications like increased uterine contractions and placental separation were also considered as secondary outcomes.
Timepoint
From drug administration to 6 hours after surgery
Method of measurement
History taking, physical exam, para-clinical assessments as indicated

Intervention groups

1

Description
"Intervention group": received a bolus of 1gm TXA (Tranexip®,Tavexamic acid, 500mg/5ml, for slow IV injection, Caspian Tamin Pharmaceutical Co, Tehran, Iran) if their body weight was <90 kg and 1.5 gram if their body weight was >90 kg diluted in 15 ml of 5% dextrose intravenously.
Category
Treatment - Drugs

2

Description
Control group: Receiving routine and 15 ml Dextrose water 5% IV injection as placebo
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Mahdiye hospital
Full name of responsible person
Zahra Naeiji
Street address
Shishegar Khane St., Fadayian Eslam Blv. Shoosh Sq.
City
Tehran
Province
Tehran
Postal code
1445763693
Phone
+98 21 5506 2628
Email
zahranaeiji98@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak,
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Preventative Gynecology Research Center
Proportion provided by this source
30
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Naeiji
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shishegar Khane St., Fadayian Eslam Blv. Shoosh Sq.
City
Tehran
Province
Tehran
Postal code
1445763693
Phone
+98 21 5506 2628
Email
zahranaeiji98@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Naeiji
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shishegar Khane St., Fadayian Eslam Blv. Shoosh Sq.
City
Tehran
Province
Tehran
Postal code
1445763693
Phone
+98 21 5506 2628
Email
zahranaeiji98@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Naeiji
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shishegar Khane St., Fadayian Eslam Blv. Shoosh Sq.
City
Tehran
Province
Tehran
Postal code
1445763693
Phone
+98 21 5506 2628
Email
zahranaeiji98@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
"There is no further information"
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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