Tranexamic Acid as an Intervention in Abruptio Placenta

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

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.

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/)

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

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. This will be followed by 500 mg tranexamic acid tablets (Trenaxa; Macleods Pharmaceuticals Pvt. Ltd.) three times daily for five days. 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.

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.

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. This will be followed by 500 mg tranexamic acid tablets (Trenaxa; Macleods Pharmaceuticals Pvt. Ltd.) three times daily for five days. 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.

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. This will be followed by 500 mg tranexamic acid tablets (Trenaxa; Macleods Pharmaceuticals Pvt. Ltd.) three times daily for five days. 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.

Delivery of newborn with APGAR scores of 7 and more, gestational age 36 weeks, and more, birth weight of 2.5 kg and more

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