Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000313831
Ethics application status
Approved
Date submitted
13/02/2012
Date registered
20/03/2012
Date last updated
20/03/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The use of tranexamic acid to reduce blood loss during and after cesarean section
Scientific title
Tranexamic acid for prevention of postpartum hemorrhage in women undergoing elective cesarean section
Secondary ID [1] 279812 0
NIL
Universal Trial Number (UTN)
U1111-1127-5142
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of Postpartum hemorrhage 285694 0
Condition category
Condition code
Reproductive Health and Childbirth 285880 285880 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tranexamic acid (1gm)will be given slowly intravenously over
10 minutes before elective cesarean section
Intervention code [1] 284134 0
Prevention
Intervention code [2] 284442 0
Treatment: Drugs
Comparator / control treatment
No treatment
Control group
Active

Outcomes
Primary outcome [1] 286377 0
Mean blood loss (ml) . The quantity of blood loss (mL) during C.S will be measure as follow= (weight of the used surgical towels minus weight of the towels prior to the surgery) + the volume sucked in the suction bottle after placental delivery in mL.
Blood loss during transfer of the patient to the postoperative care will be measured by using calibrated plastic drape put under the patients intraoperative.
In addition blood loss after the operation will be calculated separately (within 2Hour postpartum) by using a calibrated plastic drape put under the patients, So the patients can use one or two calibrated plastic drape.
Timepoint [1] 286377 0
Blood loss will be collected during and for two hours after operation
Secondary outcome [1] 295713 0
1-Blood loss 500 ml or more ( blood loss will be measured for two hours after operation using a caliberated plastic drape put under the patient).
Timepoint [1] 295713 0
During the two hours after operation
Secondary outcome [2] 295720 0
2-Blood loss 1000 ml or more (blood loss will be measured using a calibrated plastic drape put under the patient for two hours after operation).
Timepoint [2] 295720 0
During two hours after operation
Secondary outcome [3] 295721 0
3-use of additional medical intervention to control postpartum hemorrhage. The files of patients will be checked for additional medications to control PPH , for example oxytocin, methyl ergometrin, prostaglandins.
Timepoint [3] 295721 0
During the two hours postoperative
Secondary outcome [4] 295722 0
4- Use of additional surgical intervention to control PPH. The files of the patients will be checked for added surgical interventions , like compresssion sutures, ligation of uterine artery , ligation of hypogastric artery, hysterectomy.
Timepoint [4] 295722 0
During the two hours postoperative
Secondary outcome [5] 295723 0
5-Mild side effects such as (nausea, vomiting, headache, skin reaction). The files will be checked for any reported side effects or medications given to treat these side effects. For example antiemetics.
Timepoint [5] 295723 0
During the first 24 hours after operation
Secondary outcome [6] 295724 0
6-Serious adverse events as:Thromboembolic event. This willl be diagnosed clinically or using Doppler ultrasound.
Timepoint [6] 295724 0
During postoperative period till discharge from hospital

Eligibility
Key inclusion criteria
All pregnant women with single fetus planned to have elective cesarean section at greater than 36wks gestation
Minimum age
19 Years
Maximum age
49 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of medical disorders.
2. Preclampsia.
3. Antepartum hemorrhage.
3. History of thromboembolic disorders.
4. Polyhydramnios.
5. Macrosomia.
6. History of sensitivity to Tranexamic acid.
7. Patients taking anticoagulant therapy.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Women fulfilling inclusion and exclusion criteria and accepting to participate will be enrolled by opening a closed sealed envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation done using computer generated randomization table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment outside Australia
Country [1] 4088 0
Egypt
State/province [1] 4088 0
Assiut

Funding & Sponsors
Funding source category [1] 284590 0
Self funded/Unfunded
Name [1] 284590 0
Country [1] 284590 0
Egypt
Primary sponsor type
University
Name
Faculty of Medicine,Assiut University
Address
Faculty of Medicine
Assiut University St
71511 Assiut
Country
Egypt
Secondary sponsor category [1] 283508 0
Hospital
Name [1] 283508 0
Department of Obstetrics and Gynecology
Address [1] 283508 0
Women's Health Centre
Assiut University Hospital
7111 Assiut
Country [1] 283508 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286708 0
Ethical Committe,Faculty of Medicine,Assiut University
Ethics committee address [1] 286708 0
Faculty of Medicine
71511 Assiut
Egypt
Ethics committee country [1] 286708 0
Egypt
Date submitted for ethics approval [1] 286708 0
Approval date [1] 286708 0
19/06/2011
Ethics approval number [1] 286708 0
IRB 00008718

Summary
Brief summary
Bleeding after delivery is still the leading cause of maternal deaths especially in low resourced countries. Rates of delivery by cesarean section are increasing.One in three to four women are delivered by cesarean section.This trial is looking for new strategies to reduce blood loss after delivery by cesarean section.Tranexamic acid is a drug which prevents or delays lysis of blood clots after its formation .The formation of blood clot at the site of placental separation inside the uterus is an important mechanism to prevent bleeding after placental separation.This randomized controlled trial aims to evaluate the effectiveness and safety of tranexamic acid given to women at cesarean section.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33693 0
Address 33693 0
Country 33693 0
Phone 33693 0
Fax 33693 0
Email 33693 0
Contact person for public queries
Name 16940 0
Hany Abdel-Aleem
Address 16940 0
Department of Obstetrics and Gynecology
Women's Health Centre
Assiut University Hospital
71511 Assiut
Country 16940 0
Egypt
Phone 16940 0
002088 2414672
Fax 16940 0
002088 2373899
Email 16940 0
[email protected]
Contact person for scientific queries
Name 7868 0
Hany Abdel-Aleem
Address 7868 0
Department of Obstetrics and Gynecology
Women's Health Centre
Assiut University Hospital
71511 Assiut
Country 7868 0
Egypt
Phone 7868 0
002088 2414672
Fax 7868 0
002088 2373899
Email 7868 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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