Tranexamic Acid as an Intervention in Abruptio Placenta
Condition: Vaginal Bleeding; Prolonged Pregnancy
MeSH terms: Uterine Hemorrhage; Pregnancy, Prolonged; Abruptio Placentae; Hemorrhage
Study type: Interventional

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
    

Detailed 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.
    

Intervention name(s): Tranexamic acid injection; Glucose water 5%
Intervention type(s): Drug; Other
Intervention description(s): 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.
Other intervention name(s): Trenaxa; Macleods Pharmaceuticals Pvt.Ltd., Mumbai, India; Glucose B.Braun
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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/)
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Abruptio placenta; Interventional study; Perinatal mortality; vaginal bleeding