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Tranexamic Acid in the Prevention of Postpartum Hemorrhage in Elective Caesarean Section

NCT04427618 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-11-09

No results posted yet for this study

Summary

In obstetrics, postpartum haemorrhage (PPH) continues to be a major contributor to maternal morbidity and mortality worldwide. Uterine atony is the most common cause of PPH, and the prophylactic use of uterotonics, specifically oxytocin, is the standard of care for PPH prophylaxis. It is believed that tranexamic acid (TXA) can enhance the hemostatic process further by inhibiting the fibrinolytic system.

TXA is an antifibrinolytic that has been studied in many different patient population for its use in reducing blood loss ranging from gynaecological and non gynaecological surgeries, to trauma patients. It has been found to reduce mortality in treatment of patients with PPH, and recent evidence have found promising results in its use for prophylaxis of PPH.

Conditions

  • Postpartum Hemorrhage
  • Tranexamic Acid

Interventions

DRUG

Tranexamic acid

Intravenous 1g TXA (500mg/5ml, given intermittent over approximately 10 minutes) given within approximately 10 minutes before skin incision

DRUG

Normal saline

Intravenous 10ml normal saline (placebo) given within approximately 10 minutes before skin incision

Sponsors & Collaborators

  • KK Women's and Children's Hospital

    lead OTHER_GOV

Principal Investigators

  • Manisha Mathur · KK Women's and Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-23
Primary Completion
2021-10-03
Completion
2022-02-01

Countries

  • Singapore

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 NCT04427618 on ClinicalTrials.gov