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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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Address [1] 290485 0
135 King Faisal street Haram Giza
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
prof.ahmedmaged@gmail.com
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
prof.ahmedmaged@gmail.com
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
prof.ahmedmaged@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary