Topical Tranexamic Acid in Caesarean Section

NCT02492087 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2016-03-16

No results posted yet for this study

Summary

The objective of this study is to investigate whether topical application of tranexamic acid into the uterine cavity and the surgical site intra-operatively can reduce blood loss and provide better surgical haemostasis in parturients with moderate to high risk for bleeding undergoing caesarean deliveries.

Conditions

  • Postpartum Haemorrhage

Interventions

DRUG

Topical tranexamic acid

Topical tranexamic acid 2g diluted with normal saline 0.9% to a volume of 120mls solution (Concentration 16.7mg/ml)

DRUG

Normal saline 0.9%

Sterile Normal saline 0.9% 120mls solution

Sponsors & Collaborators

  • Ministry of Health, Malaysia

    collaborator OTHER_GOV
  • Dr Meng-Li Lee

    lead OTHER_GOV

Principal Investigators

  • Meng-Li Lee, FANZCA · Department of Anaesthesia, Hospital Tengku Ampuan Rahimah, Ministry of Health, Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Malaysia

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 NCT02492087 on ClinicalTrials.gov