Tranexamic Acid as an Intervention in Placenta Previa

NCT ID: NCT05688111

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-10
• Study Completion Date: 2023-12-03

Brief Summary

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

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.

Conditions

Interventional Drug in Placenta Previa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Tranexamic acid injection

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Glucose water 5%

Intervention Type: OTHER

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

Interventions

Tranexamic acid injection

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

Intervention Type: DRUG

Glucose water 5%

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

Intervention Type: OTHER

Other Intervention Names

Trenaxa; Macleods Pharmaceuticals Pvt.Ltd., Mumbai, India; Glucose B.Braun

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hawler Medical University

OTHER

Sponsor Role: lead

Responsible Party

SHAHLA KAREEM ALALAF

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SHAHLA K ALALAF, prof.

Role: PRINCIPAL_INVESTIGATOR

Hawler Medical University

Ariana Jawad, professor

Role: STUDY_DIRECTOR

Kurdistan Higher Counsel of Medical Specialties

khalida Amin, Ass. Prof

Role: STUDY_CHAIR

karkuk Medical college

Locations

Ariana kh. Jawad

Erbil, Kurdistan Region, Iraq

Kurdistan Board for Medical speciality

Erbil, Kurdistan Region, Iraq

Countries

Iraq

Other Identifiers

HawlerMU5

Identifier Type: -

Identifier Source: org_study_id