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

November 1, 2014 updated by: Mahmoud Mostafa Abdellah Mostafa, Ain Shams Maternity Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 02
        • Recruiting
        • Ain Shams Maternity Hospital
        • Contact:
        • Contact:
          • Nashwa AlSaied, M.D
          • Phone Number: 202 01005369353

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group A
receiving tranexamic acid
Drug: Tranexamic Acid
Intravenous Injection
Other Names:
  • in 200 ml saline
No Intervention: group B
does not receive tranexamic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Amount of blood loss during cesarean section after placental delivery till end of the operation.
Time Frame: during and 2hours post cesarean section
during and 2hours post cesarean section

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1.Vital signs eg:blood pressure ,heart rate ,respiratory rate during first two post operative hours .
Time Frame: up to 24hours postoperative
composite
up to 24hours postoperative
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 .
first 24 hours
24 hours post operative haemoglobin and haematocrit .
Time Frame: after 24 hours.
composite
after 24 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams Maternity Hospital

Investigators

  • Principal Investigator: Amr Abdelaziz, M.D, Ain Shams Maternity Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

March 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

October 24, 2014

First Submitted That Met QC Criteria

October 28, 2014

First Posted (Estimate)

October 30, 2014

Study Record Updates

Last Update Posted (Estimate)

November 4, 2014

Last Update Submitted That Met QC Criteria

November 1, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • septemper 2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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