Tranexamic Acid as an Intervention in Abruptio Placenta

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Vaginal Bleeding, Prolonged Pregnancy

Intervention / Treatment
-----------------
* Drug: Tranexamic acid injection
* Other: Glucose water 5%


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tranexamic acid group<br>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. | Drug: Tranexamic acid injection<br>* 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.<br>* Other names: Trenaxa; Macleods Pharmaceuticals Pvt.Ltd., Mumbai, India;|
| Placebo Comparator: Glucose water group<br>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. | Other: Glucose water 5%<br>* 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.<br>* Other names: Glucose B.Braun;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal blood loss | Vaginal bleeding soaked the underwear or requires a pad | Up to time of delivery | 
| Gestational age | Ultrasound estimation of gestational age at each admission to hospital | Up to time of delivery | 
| Favorable perinatal outcome | Delivery of newborn with APGAR scores of 7 and more, gestational age 36 weeks, and more, birth weight of 2.5 kg and more | 7 days post partum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abruptio placenta, Interventional study, Perinatal mortality, vaginal bleeding