Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000312549
Ethics application status
Approved
Date submitted
2/01/2015
Date registered
2/04/2015
Date last updated
2/04/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficiency and safety of preoperative Tranexamic acid in reducing perioperative blood loss in elective cesarean section
Scientific title
Efficiency and safety of preoperative Tranexamic acid compared to a placebo in reducing perioperative blood loss in women undergoing elective cesarean section
Secondary ID [1] 285904 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
blood loss during and after cesarean section 293821 0
Condition category
Condition code
Reproductive Health and Childbirth 294124 294124 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1 gm tranexamic acid 15 min before CS by intravenous infusion
Intervention code [1] 290880 0
Prevention
Intervention code [2] 291103 0
Treatment: Drugs
Comparator / control treatment
glucose 5% intravenous infusion
Control group
Placebo

Outcomes
Primary outcome [1] 293926 0
estimated blood loss (EBL) during and after Cesarean section
Estimated blood loss was calculated according to the following formula:
"EBL = EBV ×" "Preop Hematocrit - Postop Hematocrit" /"Preop Hematocrit"
EBL: estimated blood loss
EBV: estimated blood volume (ml) = weight (kg) x 85
Timepoint [1] 293926 0
24 hours after Cesarean section
Secondary outcome [1] 312157 0
1. postoperative hemoglobin, serum assay
Timepoint [1] 312157 0
up to 4 weeks after surgery
Secondary outcome [2] 312807 0
postoperative hematocrit, serum assay
Timepoint [2] 312807 0
4 weeks after CS
Secondary outcome [3] 312808 0
platelet count , serum assay
Timepoint [3] 312808 0
4 weeks after CS
Secondary outcome [4] 312809 0
needed postoperative ecbolics. needed drugs administered intramuscular
Timepoint [4] 312809 0
24 hours after CS

Eligibility
Key inclusion criteria
full-term singleton pregnancies underwent elective lower segment caesarean section
Minimum age
19 Years
Maximum age
41 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1.prolonged CS (> 90 min according to anesthetic record), 2.anemic patients (Hb < 9 gm %),
3.presence of maternal medical disorder (e.g. cardiac, renal, hepatic & coagulopathies) or
4.history of thrombo-embolic events.
5.known allergy to TA.
6.Patients with increased risk for obstetric hemorrhage (e.g. antepartum hemorrhage, abnormal placentation, previous history of uterine atony & postpartum hemorrhage, polyhydramnios & uterine fibroids).

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)
computer generated random numbers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2013
Actual
1/11/2013
Date of last participant enrolment
Anticipated
30/11/2014
Actual
30/11/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 6574 0
Egypt
State/province [1] 6574 0
Cairo

Funding & Sponsors
Funding source category [1] 290485 0
Self funded/Unfunded
Name [1] 290485 0
Ahmed maged
Country [1] 290485 0
Egypt
Primary sponsor type
Individual
Name
Ahmed Maged
Address
135 King Faisal street Haram Giza.Kasr Alainy medical school.Cairo university Egypt Post code 12151
Country
Egypt
Secondary sponsor category [1] 289186 0
Individual
Name [1] 289186 0
Moutaz Elsherbiny
Address [1] 289186 0
122 Kasr AlAiny street Cairo. Kasr Alainy medical school.Cairo university Egypt Post code 12398
Country [1] 289186 0
Egypt

Ethics approval
Ethics application status
Approved

Summary
Brief summary
A randomized placebo-controlled prospective study involved 200 women undergoing elective LSCS randomized to receive either 1 gm TA 15 min before CS (TA group) or glucose 5% (Placebo group). Complete blood count (CBC) was done before CS and 24 hours later. The pre- and postoperative hematocrit values and maternal weight were used to calculate the estimated blood loss (EBL) during CS which was the primary outcome measure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53746 0
A/Prof Ahmed Maged
Address 53746 0
135 King Faisal street Haram Giza Kasr Alainy medical school.Cairo university Egypt Post code 12151
Country 53746 0
Egypt
Phone 53746 0
+20201005227404
Fax 53746 0
Email 53746 0
[email protected]
Contact person for public queries
Name 53747 0
A/Prof Ahmed Maged
Address 53747 0
135 King Faisal street Haram Giza Kasr Alainy medical school.Cairo university Egypt Post code 12151
Country 53747 0
Egypt
Phone 53747 0
+20201005227404
Fax 53747 0
Email 53747 0
[email protected]
Contact person for scientific queries
Name 53748 0
A/Prof Ahmed Maged
Address 53748 0
135 King Faisal street Haram Giza Kasr Alainy medical school.Cairo university Egypt Post code 12151
Country 53748 0
Egypt
Phone 53748 0
+20201005227404
Fax 53748 0
Email 53748 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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