Tranexamic Acid Versus Misoprostol to Reduce Blood Loss During and After Cesarean Section

Comparison of the Effect of Tranexamic Acid Versus Misoprostol on Blood Loss During and After Cesarean Section

Brief Summary

The goal of this clinical trial is to compare two medicines, intravenous tranexamic acid and rectal misoprostol, for reducing blood loss in women undergoing cesarean section. The study will also compare how much hemoglobin (a measure of blood loss) decreases after surgery with each treatment.

The main questions the study aims to answer are:

1. Does intravenous tranexamic acid reduce the drop in hemoglobin more than rectal misoprostol after cesarean section?
2. Does intravenous tranexamic acid reduce blood loss during and within 2 hours after cesarean section more than rectal misoprostol?

Researchers will randomly assign 214 women scheduled for cesarean section to receive either intravenous tranexamic acid or rectal misoprostol before surgery. All cesarean sections will be performed according to the hospital's standard procedures by experienced obstetricians.

Participants will:

i. Be randomly assigned to receive either intravenous tranexamic acid or rectal misoprostol before surgery.

ii. Have their hemoglobin level measured before the cesarean section and again 2 hours after surgery.

iii. Have blood loss measured during the operation and for 2 hours after surgery.

iv. Have the duration of the operation recorded as part of the study.

The results will help determine which treatment is more effective in reducing blood loss and preserving hemoglobin levels during and after cesarean section.

Study Overview

• Status: Completed
• Conditions: Cesarean Section; Blood Loss, Surgical; Blood Loss, Postoperative
• Intervention / Treatment: Drug: Intravenous Tranexamic Acid; Drug: rectal misoprostol

• Study Type: Interventional
• Enrollment (Actual): 214
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Multan, Punjab Province, Pakistan, 60000
      • Medicare Hospital (Pvt) Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 37 to 42 weeks of gestation
• Planned cesarean section

Exclusion Criteria:

• Women with pre-eclampsia
• Chronic hypertension
• Multiple pregnancies
• Preterm or postdate pregnancy
• Previous cesarean section
• Gestational diabetes
• Fetal macrosomia
• History of bleeding / clotting disorder
• On anti-coagulation heparin / warfarin therapy
• Non-reassuring cardiotocograph or poor progress of labor

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intravenous Tranexamic Acid; Participants will receive intravenous tranexamic acid	Drug: Intravenous Tranexamic Acid; 1000 mg of intravenous tranexamic acid will be given after spinal anesthesia and before start of cesarean section
Active Comparator: Rectal Misoprostol; Participants will receive rectal Misoprostol	Drug: rectal misoprostol; 1000 μg of rectal misoprostol will be given after spinal anesthesia and before start of cesarean section

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Hemoglobin	Reduction in hemoglobin will be calculated as the difference between preoperative and 2-hour postoperative hemoglobin concentrations (g/dL).	Baseline at enrollment and postoperative within 2 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Blood Loss	Total blood loss will be measured as the sum of blood collected in the suction container during surgery and blood absorbed by pre-weighed surgical gauze and sanitary pads (1 g = 1 mL) from the start of surgery until 2 hours after cesarean section.	From the start of cesarean section to postoperatively until two hours

Collaborators and Investigators

• Sponsor: Medicare Hospital (Pvt) Limited
• Investigators: Study Chair: Shahid I Rao, FCPS, Medicare Hospital (Pvt) Limited

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Actual): August 30, 2025
• Study Completion (Actual): August 30, 2025

Study Registration Dates

• First Submitted: July 14, 2026
• First Submitted That Met QC Criteria: July 14, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Cesarean delivery; Tranexamic acid; Misoprostol; Obstetric Hemorrhage; Perioperative Blood Loss; Postpartum Hemorrhage Prevention; Hemoglobin Reduction
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Hemorrhage; Intraoperative Complications; Pathological Conditions, Signs and Symptoms; Blood Loss, Surgical; Postoperative Hemorrhage
• Other Study ID Numbers: U1111-1343-7865

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No