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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02279186 |
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Date of registration:
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24/10/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effectiveness of Intravenous Tranexamic Acid in Reducing Blood Loss During and After Cesarean Section
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Scientific title:
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Effectiveness of Intravenous Tranexamic Acid in Reducing Blood Loss During and After Cesarean Section ,A Randomized Clinical Trial . |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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200 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02279186 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
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Phase:
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Phase 4
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Nashwa AlSaied, M.D |
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Address:
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Telephone:
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01005369353 |
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Email:
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Affiliation:
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Name:
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Mahmoud Shalby, MBBCH |
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Address:
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Telephone:
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01121117275 |
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Email:
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dr_mahmoud.mostafa@yahoo.com |
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Affiliation:
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Name:
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Amr Abdelaziz, M.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ain Shams Maternity Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- - Women undergoing caesarean delivery for various elective indications.
- Full term primiparas / multiparas.
- Singleton pregnancy being delivered by LSCS.
Exclusion Criteria:
- - Medical problems involving the heart, liver, kidney and brain .
- Blood disorders.
- Allergy to tranexamic acid.
- History of thromboembolic disorders, abnormal placentation, severe pre-eclampsia,
uterine anomalies and pathology.
- Multiple pregnancy, macrosomia.
- Polyhydromnios .
- Patients requiring blood transfusion due to anemia
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Bleeding
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Intervention(s)
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Drug: Tranexamic Acid
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Primary Outcome(s)
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Amount of blood loss during cesarean section after placental delivery till end of the operation.
[Time Frame: during and 2hours post cesarean section]
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Secondary Outcome(s)
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Adverse affect of tranexamic acid on mother and neonate .
[Time Frame: first 24 hours]
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1.Vital signs eg:blood pressure ,heart rate ,respiratory rate during first two post operative hours .
[Time Frame: up to 24hours postoperative]
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24 hours post operative haemoglobin and haematocrit .
[Time Frame: after 24 hours.]
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Secondary ID(s)
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septemper 2014
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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