Tranexamic Acid as an Intervention in Abruptio Placenta

NCT05840471 | Completed DMC

• 1 other identifier: HMU5
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

Abruptio placenta is one of the common causes of antepartum haemorrhage which is more common in the second half of pregnancy and causes a high maternal and neonatal morbidity and mortality

Conditions

Vaginal Bleeding; Prolonged Pregnancy

Keywords

Abruptio placenta; Interventional study; Perinatal mortality; vaginal bleeding

Outcome Measures

Primary Outcomes (3)

• Hemostasis

  complete or gradual cessation of vaginal bleeding

  Up to time of delivery

• Gestational age

  37 weeks and more

  at time of delivery

• Favorable perinatal outcome

  viable newborn, birth weight of at least 2,500 grams, an Apgar score of at least 7, and no neonatal intensive care unit hospitalization. more, birth weight of 2.5 kg and more

  up to 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 Dextrose 5% in water 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

Dextrose 5% in water group

PLACEBO COMPARATOR

Participants will receive 30 mL of Dextrose 5% in water slowly intravenously immediately during the attack of the bleeding, twice daily for 48 hours. Accompanied with the usual expectant management care.

Other: Dextrose 5% in water

Interventions

Tranexamic acid injection DRUG

This interventional arm will receive tranexamic acid 1 g (10ml) (2 ampules each of 500 mg, 5ML) of tranexamic acid in 20 ml Dextrose 5% in water 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.

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

Tranexamic acid group

Dextrose 5% in water OTHER

This interventional arm will receive tranexamic acid 1 g(10ml) (2 ampules each of 500 mg, 5ML) of tranexamic acid in 20 ml Dextrose 5% in water 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.

Also known as: Glucose B.Braun

Dextrose 5% in water group

Eligibility Criteria

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

You may qualify if:

• weeks gestation and more
• Stable hemodynamically
• Accepted to participate

You may not qualify if:

• Hypersensitivity to tranexamic acid
• Defective color vision
• History of venous thromboembolism
• Pre-existing medical conditions that could affect pregnancy outcomes (diabetes mellitus, hypertension, renal disease)
• Smoker
• Refused to participate in the trial

Sponsors & Collaborators

• Hawler Medical University: lead

Study Sites (1)

Shahla Kareem Alalaf

Erbil, Kurdistan Region, 44001, Iraq

Location

MeSH Terms

Conditions

Uterine Hemorrhage; Pregnancy, Prolonged; Abruptio Placentae; Perinatal Death

Interventions

Tranexamic Acid; Glucose; Water

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Death

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Hexoses; Monosaccharides; Sugars; Carbohydrates; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• SHAHLA ALALAF, prof.

  Hawler Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, 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 will be done using the Randomization Allocation Software program. Blindness in each group will be confirmed by a pharmacist who is not involved in the study and will have the codes belonging to the type of 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 12, 2023
• First Posted: May 3, 2023
• Study Start: January 10, 2023
• Primary Completion: February 2, 2024
• Study Completion: February 10, 2024
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)