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Efficacy of Tranexamic Acid in Reducing Blood Loss During and After Caesarean Section

NCT02350179 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-02-10

No results posted yet for this study

Summary

The aim of this study is to evaluate the efficacy of tranexamic acid in reducing blood loss during and after elective C.S.

The Research Question Is Tranexamic acid effective in reducing blood loss during and after elective Caesarean section?

The Research Hypothesis The TXA could be able to reduce blood loss during and after elective Caesarean section.

The null hypothesis will therefore state that:

There will be no difference between TXA and placebo in reducing blood loss during and after elective Caesarean section.

Conditions

  • Hemorrhage of Cesarean Section and/or Perineal Wound

Interventions

DRUG

Tranexamic Acid

This will be a prospective, randomized controlled trial that will be carried at Obstetrics and Gynecology Department, Ain Shams Maternity Hospital. The study will include 100 pregnant women with singleton fetus 38 or more weeks gestation who will be divided in to two groups. Study group will include 50 women and control group will include 50 women. Women assigned to the study group will receive 1 gr of TXA injection (Kapron, AMOUN Pharmaceutical co.) given slowly I.V over 10 minutes before the operation. The control group will receive 30ml of 5% glucose. Both provider and patient will be double-blinded until the conclusion of the study.

DRUG

Glucose

The control group will receive 30ml of 5% glucose. Both provider and patient will be double-blinded until the conclusion of the study.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Zarafshan M Raqeeb, MS · Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-04-30
Completion
2015-05-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02350179 on ClinicalTrials.gov