Tranexamic Acid as an Intervention in Abruptio Placenta

Hawler Medical University116 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

116

Conditions

Vaginal Bleeding Prolonged Pregnancy

Interventions

Tranexamic acid injectionDRUG

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.

Dextrose 5% in waterOTHER

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Shahla Kareem Alalaf

Erbil, Kurdistan Region, Iraq

Outcomes

Primary Outcomes

Hemostasis

complete or gradual cessation of vaginal bleeding

Time frame: Up to time of delivery

Gestational age

37 weeks and more

Time frame: 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

Time frame: up to 7 days post partum

Data from ClinicalTrials.gov

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