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

NCT07712510 | Completed Phase 4

• 1 other identifier: U1111-1343-7865
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Blood Loss, Surgical; Blood Loss, Postoperative; Cesarean Section

Keywords

Tranexamic acid; Misoprostol; Cesarean delivery; Postpartum Hemorrhage Prevention; Hemoglobin Reduction; Obstetric Hemorrhage; Perioperative Blood Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Total Blood Loss

  From the start of cesarean section to postoperatively until two hours

Study Arms (2)

Intravenous Tranexamic Acid

EXPERIMENTAL

Participants will receive intravenous tranexamic acid

Drug: Intravenous Tranexamic Acid

Rectal Misoprostol

ACTIVE COMPARATOR

Participants will receive rectal Misoprostol

Drug: rectal misoprostol

Interventions

rectal misoprostol DRUG

1000 μg of rectal misoprostol will be given after spinal anesthesia and before start of cesarean section

Rectal Misoprostol

Intravenous Tranexamic Acid DRUG

1000 mg of intravenous tranexamic acid will be given after spinal anesthesia and before start of cesarean section

Intravenous Tranexamic Acid

Eligibility Criteria

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

You may qualify if:

• to 42 weeks of gestation
• Planned cesarean section

You may not qualify if:

• 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

Sponsors & Collaborators

• Medicare Hospital (Pvt) Limited: lead

Study Sites (1)

Medicare Hospital (Pvt) Limited

Multan, Punjab Province, 60000, Pakistan

Location

MeSH Terms

Conditions

Blood Loss, Surgical; Postoperative Hemorrhage

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Postoperative Complications

Study Officials

• Shahid I Rao, FCPS

  Medicare Hospital (Pvt) Limited

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 17, 2026
• Study Start: March 1, 2025
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)