Investigating the Efficacy of Tranexamic Acid as a Prophylactic Agent in Reducing Postpartum Hemorrhage Among Patients Undergoing Cesarean Section in SQUH

NCT07474077 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 338/2025
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief Summary

Investigating the efficacy of tranexamic acid (TXA) as a prophylactic agent in reducing postpartum haemorrhage (PPH) among patients undergoing cesarean section (CS) in SQUH: a prospective randomized controlled trial.

Conditions

Post Partum Haemorrhage

Keywords

Post partum haemorrhage; tranexamic acid; Caesarean section; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Measured blood loss from skin incision to 24 hours postpartum using calibrated drapes (intra-op)

  Measured blood loss from skin incision to 24 hours postpartum using calibrated drapes (intra-op) + gravimetric method (pads/linens) and suction canister accounting for irrigation, and Incidence of PPH ≥1000 mL within 24 hours after CS.

  18 months

Study Arms (2)

Tranexamic acid

EXPERIMENTAL

Women who receive intravenous, Tranexamic acid for prophylaxis of postpartum hemorrhage

Drug: tranexamic acid (1 g diluted in 100 mL of 0.9% saline

Normal Saline

PLACEBO COMPARATOR

Women who will receive 0.9% saline, intravenous, volume matched

Drug: Normal (0.9%) saline

Interventions

tranexamic acid (1 g diluted in 100 mL of 0.9% saline DRUG

This intervention is currently used for treatment of postpartum hemorrhage and not a routine prophylaxis

Tranexamic acid

Normal (0.9%) saline DRUG

Intravenous volume matched normal 0.9% saline

Normal Saline

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant woman with risk factors for postpartum haemorrhage undergoing elective and emergency caesarean section in SQUH.
• Previous Caesarean Section
• Multiple pregnancy,
• Polyhydramnios,
• Fetal macrosomia (BW \>4kg),
• Anemia
• Booking BMI\>30
• Previous history of postpartum hemorrhage
• Fibroids,
• Adenomyosis,
• Placenta previa (non- accreta),
• Chorioamnionitis.

You may not qualify if:

• Placenta accreta spectrum,
• Contraindications to tranexamic acid (e.g., hypersensitivity to tranexamic acid), -History of seizure disorders,
• Kidney disease,
• Thromboembolic disease,
• Medical conditions or treatments associated with a high risk of thrombosis

Sponsors & Collaborators

• Sultan Qaboos University: lead

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Tranexamic Acid; Sodium Chloride

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Vaidyanathan Gowri, Doctor

CONTACT

+968 99416909; gowri@squ.edu.om

Meenakshi R Menon, Doctor

CONTACT

+968 91378237; m.ram@squ.edu.om

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 16, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03