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

NCT07013812 | Completed Phase 4

• 1 other identifier: U1111-1323-6469
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section; Blood Loss During Surgery

Keywords

Tranexamic acid; Elective Cesarean Section; Intraoperative blood loss

Outcome Measures

Primary Outcomes (1)

• Blood Loss

  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.

  During the elective cesarean section procedure

Study Arms (2)

Intravenous Tranexamic Acid

EXPERIMENTAL

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.

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

Intravenous 5% Dextrose

PLACEBO COMPARATOR

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.

Drug: Dextrose 5% (D5W)

Interventions

Tranexamic Acid (IV) DRUG

One gram (10 ml) intravenous injection

Also known as: TXA, Cyklokapron, Lysteda, Transamin.

Intravenous Tranexamic Acid

Dextrose 5% (D5W) DRUG

5% dextrose water intravenously

Intravenous 5% Dextrose; Intravenous Tranexamic Acid

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Combined Military Hospital Multan: lead

Study Sites (1)

Combined Military Hospital

Multan, Punjab Province, 60000, Pakistan

Location

Related Publications (2)

• Abu-Zaid A, Baradwan S, Badghish E, AlSghan R, Ghazi A, Albouq B, Khadawardi K, AlNaim NF, AlNaim LF, Fodaneel M, AbuAlsaud FS, Jamjoom MZ, Almubarki AA, Alsehaimi SO, Alabdrabalamir S, Alomar O, Al-Badawi IA, Salem H. Prophylactic tranexamic acid to reduce blood loss and related morbidities during hysterectomy: a systematic review and meta-analysis of randomized controlled trials. Obstet Gynecol Sci. 2022 Sep;65(5):406-419. doi: 10.5468/ogs.22115. Epub 2022 Jul 28.

  PMID: 35896179 BACKGROUND

• Shalaby MA, Maged AM, Al-Asmar A, El Mahy M, Al-Mohamady M, Rund NMA. Safety and efficacy of preoperative tranexamic acid in reducing intraoperative and postoperative blood loss in high-risk women undergoing cesarean delivery: a randomized controlled trial. BMC Pregnancy Childbirth. 2022 Mar 14;22(1):201. doi: 10.1186/s12884-022-04530-4.

  PMID: 35287618 BACKGROUND

MeSH Terms

Interventions

Tranexamic Acid; Glucose

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Nidda Y Professor, FCPS

  Combined Military Hospital Multan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 10, 2025
• Study Start: November 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)