Prevention of Postpartum Haemorrhage

July 8, 2020 updated by: Dr. Abou Bakr Mohamed El Nashaar, Benha University

Tranexamic Acid for the Prevention of Postpartum Haemorrhage

Use of Tranexamic Acid for prevention of Postpartum hemorrhage in high risk patients: Randomized Control Trial

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study aims to assess the efficacy of administration of Tranexamic Acid in preventing Postpartum haemorrhage & reducing intraoperative and postoperative blood loss in high risk women for Postpartum Hemorrhage undergoing caesarean section. Studying its benefit to transfusion-sparing and hysterectomy-sparing. & reduction of hemorrhage-related mortality when Postpartum hemorrhage is expected.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: Shaimaa ezzat
  • Phone Number: 00201009023289

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Police Hospital
        • Contact:
          • Shaimaa ezzat
          • Phone Number: 00201009023289

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women at high risk for postpartum hemorrhage after cesarean section

Exclusion Criteria:

  • women who are not at high risk for postpartum hemorrhage , or attending for normal vaginal delivery.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Study
Tranexamic acid 1 gm (100 mg/ml) slowly intravenous infusion during delivery ( administered over 10 minutes at 1 ml/minute) .
Drug: Tranexamic acid injection
1 gm (100 mg/ml) slowly intravenous infusion during delivery ( administered over 10 minutes at 1 ml/minute) .
Other Names:
  • Kapron, 500 mg/5ml
No Intervention: Control
control group will not be given tranexamic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood loss
Time Frame: immediately after deliver
Estimation of blood loss
immediately after deliver

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood pressure
Time Frame: immediately after delivery
blood pressure
immediately after delivery
pulse
Time Frame: immediately after delivery
pulse
immediately after delivery
temperature
Time Frame: immeditely after delivery
temperature
immeditely after delivery

Collaborators and Investigators

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

Sponsor

Benha University

Investigators

  • Principal Investigator: Shaimaa Ezzat, Police 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 (Actual)

April 30, 2020

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

April 30, 2020

First Submitted That Met QC Criteria

July 8, 2020

First Posted (Actual)

July 9, 2020

Study Record Updates

Last Update Posted (Actual)

July 9, 2020

Last Update Submitted That Met QC Criteria

July 8, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tranexamic

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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