Tranexamic Acid as an Intervention in Abruptio Placenta

Hawler Medical University

Status: Completed

Conditions: Vaginal Bleeding; Prolonged Pregnancy

Treatments: Other: Dextrose 5% in water; Drug: Tranexamic acid injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05840471

HMU5

Details and patient eligibility

About

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

Full description

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.

Enrollment: 116 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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116 participants in 2 patient groups, including a placebo group

Tranexamic acid group

Active Comparator group

Description:

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.

Treatment:

Drug: Tranexamic acid injection

Dextrose 5% in water group

Placebo Comparator group

Description:

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.

Treatment:

Other: Dextrose 5% in water