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Tranexamic Acid for the Prevention of Postpartum Haemorrhage

NCT04707950 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-01-13

No results posted yet for this study

Summary

Use of tranexamic acid (TXA) for the prevention of postpartum haemorrhage (PPH) after cesarean section in high-risk patients ( a randomized control trial ).

Conditions

  • Postpartum Hemorrhage

Interventions

DRUG

Tranexamic Acid 100 milligram/Milliliter

Participants will be divided into two groups: a study group \& a control group. In addition to the standard management, the study group will be given TXA 1 gm (100 mg/ml) slowly intravenous infusion during delivery after clamping of the cord (administered over 10 minutes at 1 ml/minute). The second dose of TXA 1 g Intravenous can be given if: * Bleeding continues after 30 minutes * Bleeding restarts within 24 hours of completing the first dose While the control group will not be given TXA and we will compare the results in both groups (amount of blood loss during operation to assess the efficacy of TXA in the prevention of PPH and reduction of intraoperative and postoperative blood loss and to assess its safety and benefit in the reduction of incidence of hysterectomy or blood transfusion requirements).

DRUG

Oxytocin

both groups will be given oxytocin as a standard management

Sponsors & Collaborators

  • Benha University

    lead OTHER

Principal Investigators

  • Abubaker M Elnashar, MD · Benha Faculty of Medecine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2021-02-25
Completion
2021-03-30

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 NCT04707950 on ClinicalTrials.gov