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NCT02279186 Clinical Trial

Effectiveness of Intravenous Tranexamic Acid in Reducing Blood Loss During and After Cesarean Section

Bleeding Clinical Trial

Official title:
Effectiveness of Intravenous Tranexamic Acid in Reducing Blood Loss During and After Cesarean Section ,A Randomized Clinical Trial .

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02279186
Other study ID # septemper 2014
Secondary ID
Status Recruiting
Phase Phase 4
First received October 24, 2014
Last updated November 1, 2014
Start date September 2014
Est. completion date September 2015

Study information
Verified date November 2014
Source Ain Shams Maternity Hospital
Contact Mahmoud Shalby, MBBCH
Phone 01121117275
Email dr_mahmoud.mostafa@yahoo.com
Is FDA regulated No
Health authority Egypt: Ministry of Higher Education
Study type Interventional

Clinical Trial Summary

In this study, the efficacy and safety of tranexamic acid in the reducing the blood loss during and after elective LSCS will be investigated.

Description:

To state the effectiveness clinically and laboratory and safety of tranexamic acid in reducing blood loss during and after the elective lower segment cesarean section.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date September 2015
Est. primary completion date March 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Drug:
• Tranexamic Acid
Intravenous Injection

Locations
Country Name City State
Egypt Ain Shams Maternity Hospital Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Amount of blood loss during cesarean section after placental delivery till end of the operation. during and 2hours post cesarean section Yes
Secondary 1.Vital signs eg:blood pressure ,heart rate ,respiratory rate during first two post operative hours . composite up to 24hours postoperative Yes
Secondary Adverse affect of tranexamic acid on mother and neonate . eg:drug allergy ,drug interaction ,thrombotic manifestation and the number of participant . first 24 hours Yes
Secondary 24 hours post operative haemoglobin and haematocrit . composite after 24 hours. Yes
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