Tranexamic Acid in Preventing Postpartum Hemorrhage in High Risk Pregnancies During Elective Cesarean Section

November 22, 2017 updated by: Hanan Nabil, Mansoura University

The Effect of Tranexamic Acid in Preventing Postpartum Hemorrhage in High Risk Pregnancies During Elective Cesarean Section, a Randomized Controlled Clinical Trial

postpartum hemorrhage (PPT) represents one of the major causes of maternal mortality . Tranexamic acid is used in many studies in management of PPH in combination with ecobolics. this study aims to evaluate the possible value of the use of tranexamic acid in prevention of postpartum hemorrhage .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 2
  • Phase 3

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

20 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Gestational age of 28 weeks or more.
  • Chronic Hypertension.
  • Preeclapmsia -Eclampsia.
  • Multiple pregnancy.
  • Uterine Liomyomas.
  • Polyhydraminos.
  • Fetal macrosomia.
  • Associated Thrombocytopenia
  • History of postpartum hemorrhage.

Exclusion Criteria:

  • Patients with rheumatic heart disease.
  • Patients with history Cardiac Valve Replacement.
  • Current or past history of DVT.
  • Women on any anticoagulant therapy.
  • Sensitivity to tranexamic acid
  • Pregnancies with any abnormally implanted or located placenta.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tranexamic acid group
Drug: Tranexamic Acid
Tranexamic acid (Kepron, Amoun, Egypt) was given slowly intravenously over 10 minutes just before the skin incision of elective cesarean section to group A. Tranexamic acid injection was prepared by diluting 1g (10 mL) tranexamic acid into 20 ml of 5% glucose.
No Intervention: non tranexamic (control) group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevention of postpartum hemorrhage in high risk group
Time Frame: intraoperative
assessment of intraoperative blood loss
intraoperative

Collaborators and Investigators

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

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Hanan Nabil, MD, Mansoura University

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)

August 1, 2016

Primary Completion (Actual)

April 15, 2017

Study Completion (Actual)

April 15, 2017

Study Registration Dates

First Submitted

November 20, 2017

First Submitted That Met QC Criteria

November 20, 2017

First Posted (Actual)

November 24, 2017

Study Record Updates

Last Update Posted (Actual)

November 27, 2017

Last Update Submitted That Met QC Criteria

November 22, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MansuraU

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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