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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02279186
Recruitment Status : Unknown
Verified November 2014 by Mahmoud Mostafa Abdellah Mostafa, Ain Shams Maternity Hospital.
Recruitment status was:  Recruiting
First Posted : October 30, 2014
Last Update Posted : November 4, 2014
Sponsor:
Information provided by (Responsible Party):
Mahmoud Mostafa Abdellah Mostafa, Ain Shams Maternity Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Bleeding Drug: Tranexamic Acid Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effectiveness of Intravenous Tranexamic Acid in Reducing Blood Loss During and After Cesarean Section ,A Randomized Clinical Trial .
Study Start Date : September 2014
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: group A
receiving tranexamic acid
Drug: Tranexamic Acid
Intravenous Injection
Other Name: in 200 ml saline

No Intervention: group B
does not receive tranexamic acid



Primary Outcome Measures :
  1. Amount of blood loss during cesarean section after placental delivery till end of the operation. [ Time Frame: during and 2hours post cesarean section ]

Secondary Outcome Measures :
  1. 1.Vital signs eg:blood pressure ,heart rate ,respiratory rate during first two post operative hours . [ Time Frame: up to 24hours postoperative ]
    composite

  2. Adverse affect of tranexamic acid on mother and neonate . [ Time Frame: first 24 hours ]
    eg:drug allergy ,drug interaction ,thrombotic manifestation and the number of participant .

  3. 24 hours post operative haemoglobin and haematocrit . [ Time Frame: after 24 hours. ]
    composite



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279186


Contacts
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Contact: Mahmoud Shalby, MBBCH 01121117275 ext 202 dr_mahmoud.mostafa@yahoo.com
Contact: Amr Abdelaziz, M.D 01001783383 ext 202 dr_AmrAziz@hotmail.com

Locations
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Egypt
Ain Shams Maternity Hospital Recruiting
Cairo, Egypt, 02
Contact: Nashwa AlSaied, M.D    01005369353 ext 202      
Contact: Amr Abdelaziz, M.D    01001783383 ext 202    dr_AmrAziz@hotmail.com   
Sponsors and Collaborators
Ain Shams Maternity Hospital
Investigators
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Principal Investigator: Amr Abdelaziz, M.D Ain Shams Maternity Hospital

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Responsible Party: Mahmoud Mostafa Abdellah Mostafa, Effectiveness of Intravenous Tranexamic Acid in Reducing Blood Loss During and After Cesarean Section ,A Randomized Clinical Trial., Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT02279186    
Other Study ID Numbers: septemper 2014
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: November 4, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants