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

Combined Military Hospital Multan

Status and phase: Completed; Phase 4

Conditions: Cesarean Section; Blood Loss During Surgery

Treatments: Drug: Tranexamic Acid (IV); Drug: Dextrose 5% (D5W)

Study type: Interventional

Funder types: Other

Identifiers

NCT07013812

U1111-1323-6469

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups, including a placebo group

Intravenous Tranexamic Acid

Experimental group

Description:

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.

Treatment:

Drug: Dextrose 5% (D5W)

Drug: Tranexamic Acid (IV)

Intravenous 5% Dextrose

Placebo Comparator group

Description:

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.

Treatment:

Drug: Dextrose 5% (D5W)