Tranexamic Acid as an Intervention in Placenta Previa

Study Overview
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Brief Summary
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Antepartum hemorrhage (APH) due to placenta previa is an important cause of worldwide perinatal mortality and maternal morbidity in pregnant women

Detailed Description
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Antepartum hemorrhage (APH) due to placenta previa is an important cause of worldwide perinatal mortality and maternal morbidity in pregnant women. No medication is of specific benefit to a patient with placenta previa. Tocolysis may be cautiously considered in some circumstances in order to administer antenatal corticosteroids. A review article concluded that there is no improvement in perinatal outcome with prolonged tocolytics, and tocolysis beyond 48 hours is not clinically indicated.

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

Conditions
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Interventional Drug in Placenta Previa

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant at 24 weeks gestation and more Vaginal bleeding due to placenta previa Stable hemodynamically Accept to participate in the trial Exclusion Criteria: Hypersensitivity to tranexamic acid Acquired defective color vision History of venous thromboembolism Pre-existing medical conditions (diabetes mellitus, hypertension, renal disease) Smokers Refused to participate in the trial

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

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization for both groups to the 2 groups will be done using Randomization Allocation Software program and whom will add the numbers on each syringe will be a pharmacist not involve in the study and will have the cods belong to the type of the intervention with him until the end of the research . Random Allocation Software(https://random-allocation-software.software.informer.com/2.0/)
Masking: Triple


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>* Active group will receive 1gm Tranexamic acid 12 hourly for 48 hours<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>* Placebo group 30ml will be received 12 hourly for 48 hours<br>* Other names: Glucose B.Braun;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To stope or decrease vaginal bleeding | Receiving Tranexamic acid decreases or stops vaginal bleeding in women with placenta previa | Up to time of delivery | 
| Prolong pregnancy to 36 weeks | Decreased vaginal bleeding may prolong pregnancy | Up to delivery of the fetus | 
| Favorable perinatal outcome | Delivery of active newborn at or more than 36 weeks gestation | 7 days post partum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Placenta previa, Tranexamic acid, intervention, Double blind