Tranexamic Acid as an Intervention in Placenta Previa

Tranexamic Acid in Pregnant Women With Placentae Previa: A Double-blind, Multicenter Randomized Clinical Trial

Antepartum hemorrhage (APH) due to placenta previa is an important cause of worldwide perinatal mortality and maternal morbidity in pregnant women

Study Overview

• Status: Completed
• Conditions: Interventional Drug in Placenta Previa
• Intervention / Treatment: Drug: Tranexamic acid injection; Other: Glucose water 5%

Detailed Description

Antepartum hemorrhage (APH) due to placenta previa is an important cause of worldwide perinatal mortality and maternal morbidity in pregnant women. No medication is of specific benefit to a patient with placenta previa. Tocolysis may be cautiously considered in some circumstances in order to administer antenatal corticosteroids. A review article concluded that there is no improvement in perinatal outcome with prolonged tocolytics, and tocolysis beyond 48 hours is not clinically indicated.

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Kurdistan Region
    • Erbil, Kurdistan Region, Iraq, 44001
      • Kurdistan Board for Medical speciality
    • Erbil, Kurdistan Region, Iraq, 44001
      • Ariana kh. Jawad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pregnant at 28 weeks gestation and more
• Vaginal bleeding due to placenta previa
• Stable hemodynamically
• Accept to participate in the trial

Exclusion Criteria:

• Hypersensitivity to tranexamic acid
• Acquired defective color vision
• History of venous thromboembolism
• Pre-existing medical conditions (diabetes mellitus, hypertension, renal disease)
• Smokers
• Refused to participate in the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Glucose water group; Participants will receive 30 mL of 5% glucose water slowly intravenously immediately during the attack of the bleeding, twice daily for 48 hours. Accompanied with the usual expectant management care.	Other: Glucose water 5%; Placebo group 30ml will be received 12 hourly for 48 hours; Other Names: Glucose B.Braun
Active Comparator: Tranexamic acid group; This interventional arm will receive tranexamic acid 1 g(10ml) (2 ampules each of 500 mg, 5ML) of tranexamic acid in 20 ml glucose water 5% intravenously twice daily in the acute stage of bleeding for 48 hours. Participants will be followed up for recurrence of bleeding during pregnancy. The course of treatment will be repeated again if bleeding recurred. The hospital data safety and monitoring board ensured the continued safety of the Participants.	Drug: Tranexamic acid injection; Active group will receive 1gm Tranexamic acid 12 hourly for 48 hours; Other Names: Trenaxa; Macleods Pharmaceuticals Pvt.Ltd., Mumbai, India

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To stope or decrease vaginal bleeding	Receiving Tranexamic acid decreases or stops vaginal bleeding in women with placenta previa	Up to time of delivery
Prolong pregnancy to 36 weeks	Decreased vaginal bleeding may prolong pregnancy	Up to delivery of the fetus
Favorable perinatal outcome	Delivery of active newborn at or more than 36 weeks gestation	7 days post partum

Collaborators and Investigators

• Sponsor: Hawler Medical University
• Investigators: Principal Investigator: SHAHLA K ALALAF, prof., Hawler Medical University; Study Director: Ariana Jawad, professor, Kurdistan Higher Counsel of Medical Specialties; Study Chair: khalida Amin, Ass. Prof, karkuk Medical college

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2022
• Primary Completion (Actual): December 3, 2023
• Study Completion (Actual): December 3, 2023

Study Registration Dates

• First Submitted: January 8, 2023
• First Submitted That Met QC Criteria: January 8, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 23, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: intervention; Tranexamic acid; Double blind; Placenta previa
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Placenta Diseases; Placenta Previa; Molecular Mechanisms of Pharmacological Action; Antifibrinolytic Agents; Fibrin Modulating Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: HawlerMU5

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No