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Tranexamic Acid Versus Sublingual Misoprostol in Reducing Blood Loss During Elective CS in High Risk Cases

NCT04117243 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 345

Last updated 2025-07-28

No results posted yet for this study

Summary

The Efficacy and safety of Preoperative Intravenous Tranexamic acid versus Sublingual misoprostol in reducing blood loss during and after Elective Cesarean section among high risk pregnant cases.

Conditions

  • Post Partum Hemorrhage

Interventions

DRUG

Misoprostol

patients will be given 400 microgram misoprostol (2 tablets - Cytotec, Pfizer, G.D. Searle LLC) sublingually immediately before starting skin incision (n=115)

DRUG

Tranexamic acid

patients will be given 1 gm (10 ml) TXA (Kapron, Amoun, Egypt) diluted in 20 ml of Glucose 5% (administered as intravenous infusion over 5 minutes, at least 15 minutes prior to skin incision) (n=115)

DRUG

Oxytocin

patients will receive an intravenous bolus of 5 IU oxytocin (Syntocinon, Novartis, Basel, Switzerland) and 20 IU oxytocin in 500 mL lactated Ringer's solution (infused at a rate of 125 mL/h) following the delivery of the baby (n=115)

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Moutaz Elsherbini, MD · assistant professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-01-20
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

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 NCT04117243 on ClinicalTrials.gov