CompletedPhase 4

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

Pakistan214 participantsStarted 2025-03-01

Plain-language 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.

Who can participate

Age range

20 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Reduction in Hemoglobin

Timeframe: Baseline at enrollment and postoperative within 2 hours

Trial details

NCT IDNCT07712510

SponsorMedicare Hospital (Pvt) Limited

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-30

View on ClinicalTrials.gov More Blood Loss, Surgical trials