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

Phase 1

Not yet recruiting

• Conditions: Post Partum Hemorrhage
• Interventions: Drug: Tranexamic Acid (TXA); Device: Placebo

• Registration Number: NCT07002749
• Lead Sponsor: Patel Hospital, Pakistan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-18
• Study First Submitted QC: 2025-05-25
• Last Update Submitted: 2025-05-25
• Study Start: 2025-06-01
• Primary Completion: 2025-06-01
• Study First Posted: 2025-06-04
• Last Update Posted: 2025-06-04
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 104

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Tranexamic Acid (TXA)	tranexamic acid
B	Placebo	-

Primary Outcome Measures

Name	Time	Method
prophylactic tranexamic acid in prevention of post-partum haemorrhage in ELLSCS	6 months from the time of approval from CPSP till the completion of data collection	In this study, the role of tranexamic acid is being observed in preventing PPH in women undergoing ELLSCS by dividing women into two groups and giving one group placebo while the other would receive tranexamic acid.; Two boxes, A and B, each containing 52 vials of the same size and color; one would contain the drug, i.e: TXA 1000 mg in 10 ml , while the other would contain a placebo in 10 ml vial, provided by a company; these would be revealed at the end of the study. A jar containing 104 chits, 52 of which would have the letter A written on them and the other 52 would have the letter B, would be kept in GYNAE OT. Prior to ELLSCS, a chit would be selected from the jar, and the patient would be given the drug according to the chit. It's a triple-blinded study; the patient, doctor, surgeon, and data analyst all will be blinded.

Trial Locations

Locations (1)

Patel Hospital; 🇵🇰 Karachi, Sindh, Pakistan