Tranexamic Acid to Reduce Blood Loss in Women Having Planned Cesarean Section

Phase 4

Completed

• Conditions: Cesarean Section; Blood Loss During Surgery
• Interventions: Drug: Tranexamic Acid (IV); Drug: Dextrose 5% (D5W)

• Registration Number: NCT07013812
• Lead Sponsor: Combined Military Hospital Multan

Brief Summary

This clinical trial was done to find out if tranexamic acid (TXA) can safely reduce the amount of blood loss during cesarean (C-section) deliveries. Heavy bleeding is a major risk during childbirth, especially in C-sections, and can be life-threatening.

The main question this study wanted to answer was:

Does giving tranexamic acid before surgery reduce the amount of blood lost during a planned C-section?

In this study, 68 women who were scheduled for elective (planned) C-section deliveries were randomly assigned to receive either tranexamic acid or a placebo (a look-alike substance with no medicine in it) before surgery. The medication was given by slow injection just 15 minutes before the operation.

All surgeries followed the same procedure and were done by experienced obstetric surgeons. The amount of blood lost during surgery was carefully measured and compared between the two groups.

The goal was to find a simple and safe way to lower the risk of blood loss and its complications during C-sections, improving outcomes for mothers.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-01
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Study First Submitted: 2025-05-30
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-06
• Last Update Submitted: 2025-06-06
• Study First Posted: 2025-06-10
• Last Update Posted: 2025-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

Inclusion Criteria

• Women age 20-45 years
• at 37-40 weeks of gestation (on LMP)
• Planned to undergo cesarean section under spinal anesthesia

Exclusion Criteria

• Women with previous history of thromboembolic events
• Allergy to tranexamic acid
• Women with morbidly adherent placenta (on antenatal USG)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous Tranexamic Acid	Tranexamic Acid (IV)	Patients received 1 g (10 ml) of tranexamic acid diluted in 20 mL of glucose 5%. Fifteen minutes before the surgery, the solution was injected intravenously slowly over a period of 5 minutes.
Intravenous Tranexamic Acid	Dextrose 5% (D5W)	Patients received 1 g (10 ml) of tranexamic acid diluted in 20 mL of glucose 5%. Fifteen minutes before the surgery, the solution was injected intravenously slowly over a period of 5 minutes.
Intravenous 5% Dextrose	Dextrose 5% (D5W)	Patients in this group received 30 mL of glucose 5%. Fifteen minutes before the surgery, the solution was injected intravenously slowly over a period of 5 minutes.

Primary Outcome Measures

Name	Time	Method
Blood Loss	During the elective cesarean section procedure	Intraoperative blood loss (ml) was measured by taking weight difference of the dressings and towels before and after the operation plus blood added to the fluid volume inside the suction apparatus.

Trial Locations

Locations (1)

Combined Military Hospital; 🇵🇰 Multan, Punjab, Pakistan