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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorSultan Qaboos University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Previous Caesarean Section

Multiple pregnancy,

Polyhydramnios,

Fetal macrosomia (BW >4kg),

Disqualifiers

Placenta accreta spectrum,

Contraindications to tranexamic acid (e.g., hypersensitivity to tranexamic acid), -History of seizure disorders,

Kidney disease,

Thromboembolic disease,

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • Normal (0.9%) saline

    Drug

    Intravenous volume matched normal 0.9% saline

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: Tranexamic acidExperimental treatment 1 intervention
Group B: Normal SalinePlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
18 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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