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Completed

NCT Number: NCT05840471

Tranexamic Acid as an Intervention in Abruptio Placenta

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

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Key information

Conditions

Vaginal Bleeding Abruptio Placentae Death Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Perinatal Death Placenta Diseases Pregnancy Complications Pregnancy, Prolonged Prolonged Pregnancy Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shahla Kareem Alalaf

Erbil, Kurdistan Region, 44001, Iraq

About this study

Abruption has been estimated to occur in 6.5 pregnancies per 1000 births, with an associated perinatal mortality rate of 119 per 1000 in the United States. A Cochrane database study revealed that there is no evidence from trials to show the best way to help pregnant women and their fetuses when there is a placental abruption. The baby may need to be delivered immediately, by cesarean section if alive, and often vaginally if the baby has died. Treatments include pain relief, blood transfusion, and monitoring. Bleeding during pregnancy is characterized by activation of the fibrinolytic system. Tranexamic acid is a potent pharmaceutical agent that suppresses fibrinolysis and thus can be used for managing hemorrhage in pregnancy. The FDA's pregnancy category for tranexamic acid is category B.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Trenaxa; Macleods Pharmaceuticals Pvt.Ltd., Mumbai, India

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.

Other names: Glucose B.Braun

Primary outcomes

  1. Hemostasis

    Time frame: Up to time of delivery

    complete or gradual cessation of vaginal bleeding

  2. Gestational age

    Time frame: at time of delivery

    37 weeks and more

  3. Favorable perinatal outcome

    Time frame: up to 7 days post partum

    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

Sponsors and collaborators

Lead sponsor

Hawler Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 3, 2023
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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