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Not yet recruiting NCT07002749

ROLE OF PROPHYLACTIC TRANEXAMIC ACID IN PREVENTION OF POST-PARTUM HEMORRHAGE IN ELLSCS

Phase I Interventional Post Partum Hemorrhage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tranexamic Acid (TXA), Placebo.
Who it may be relevant to
Registry conditions: Post Partum Hemorrhage. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

IN THIS STUDY WOMEN UNDER GOING ELLSCS WOULD BE DIVIDED INTO TWO GROUPS , ONE GROUP WOULD BE GIVEN TRANEXAMIC ACID WHILE THE OTHER WOULD BE GETTING PLACEBO PROPHYLACTICALLY TO SEE THE EFFECT OF TRANEXAMIC ACID IN PREVENTING PPH. THIS IS A RANDOMIZED CONTROLLED TRIAL. THE SAMPLING TECHNIQUE WOULD BE NON-PROBABILITY TECHNIQUE RANDOMIZATION WOULD BE DONE VIA BALLOTING METHOD.

Interventions

  • Drug Tranexamic Acid (TXA)
    I would like to see the effect of prophylactic tranexamic acid in women undergoing ELLSCS in preventing PPH in my setup.
  • Device Placebo
    one group will get placebo

Primary outcome measures

  • prophylactic tranexamic acid in prevention of post-partum haemorrhage in ELLSCS [Time frame: 6 months from the time of approval from CPSP till the completion of data collection]

Eligibility criteria

Inclusion criteria

  • Pregnant women with singleton pregnancy and low risk for PPH admitted for ELLSCS

Exclusion criteria

Women with medical disorder or complex pregnancy.

  • Women with history of PPH.
  • Women with bleeding disorder.
  • Abnormal placentation (MAP, placenta previa)
  • Multiple pregnancy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Patel Hospital — Karachi

Identifiers

NCT: NCT07002749 · PH/IRB/2025/002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗