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NCT Number: NCT07712510

Tranexamic Acid Versus Misoprostol to Reduce 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.

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Key information

Conditions

Blood Loss, Surgical Blood Loss, Postoperative Cesarean Section Hemorrhage Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hemorrhage

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Medicare Hospital (Pvt) Limited

Multan, Punjab Province, 60000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous tranexamic acid

Drug

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

Rectal Misoprostol

Drug

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

Primary outcomes

  1. Reduction in Hemoglobin

    Time frame: Baseline at enrollment and postoperative within 2 hours

    Reduction in hemoglobin will be calculated as the difference between preoperative and 2-hour postoperative hemoglobin concentrations (g/dL).

Other outcomes

  1. Total Blood Loss

    Time frame: From the start of cesarean section to postoperatively until two hours

    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.

Sponsors and collaborators

Lead sponsor

Medicare Hospital (Pvt) Limited

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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