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

NCT07712510 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2026-07-17

No results posted yet for this study

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. 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.

Conditions

  • Blood Loss, Surgical
  • Blood Loss, Postoperative
  • Cesarean Section

Interventions

DRUG

Intravenous Tranexamic Acid

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

DRUG

rectal misoprostol

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

Sponsors & Collaborators

  • Medicare Hospital (Pvt) Limited

    lead OTHER

Principal Investigators

  • Shahid I Rao, FCPS · Medicare Hospital (Pvt) Limited

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2025-08-30
Completion
2025-08-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07712510 on ClinicalTrials.gov