Tranexamic Acid as an Intervention in Placenta Previa

NCT05688111 | Completed DMC

• 1 other identifier: HawlerMU5
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Interventional Drug in Placenta Previa

Keywords

Placenta previa; Tranexamic acid; intervention; Double blind

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Tranexamic acid group

ACTIVE COMPARATOR

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

Glucose water group

PLACEBO COMPARATOR

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%

Interventions

Tranexamic acid injection DRUG

Active group will receive 1gm Tranexamic acid 12 hourly for 48 hours

Also known as: Trenaxa; Macleods Pharmaceuticals Pvt.Ltd., Mumbai, India

Tranexamic acid group

Glucose water 5% OTHER

Placebo group 30ml will be received 12 hourly for 48 hours

Also known as: Glucose B.Braun

Glucose water group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hawler Medical University: lead

Study Sites (2)

Ariana kh. Jawad

Erbil, Kurdistan Region, 44001, Iraq

Location

Kurdistan Board for Medical speciality

Erbil, Kurdistan Region, 44001, Iraq

Location

MeSH Terms

Conditions

Placenta Previa

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• SHAHLA K ALALAF, prof.

  Hawler Medical University

  PRINCIPAL INVESTIGATOR

• Ariana Jawad, professor

  Kurdistan Higher Counsel of Medical Specialties

  STUDY DIRECTOR

• khalida Amin, Ass. Prof

  karkuk Medical college

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Two similar size syringes will be prepared and labeled as A (experimental group) containing 1 g/10mL Tranexamic acid diluted with 20mL of 5% glucose water, and syringe B (placebo group) containing 30 mL of 5% glucose water. The 2 groups of syringes will be labeled with different numbers not known by the investigator or the patient
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomization for both groups to the 2 groups will be done using Randomization Allocation Software program and whom will add the numbers on each syringe will be a pharmacist not involve in the study and will have the cods belong to the type of the intervention with him until the end of the research . Random Allocation Software(https://random-allocation-software.software.informer.com/2.0/)

Study Record Dates

• First Submitted: January 8, 2023
• First Posted: January 18, 2023
• Study Start: December 10, 2022
• Primary Completion: December 3, 2023
• Study Completion: December 3, 2023
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

IR (2)