Antenatal Tranexamic Acid in Women With Symptomatic Placenta Previa

Study Overview
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Brief Summary
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200 pregnant women with symptomatic placenta previa with previous bleeding attacks attending Ain Shams University maternity hospital will be recruited and randomized to receive either tranexamic acid tablets (500mg four times daily) or placebo. Amount of bleeding during antepartum bleeding attacks will be estimated (by hemoglobin change from baseline at admission till delivery).

Official Title
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Efficacy of Antenatal Tranexamic Acid in Pregnant Women With Symptomatic Placenta Previa in Decreasing Antepartum Hemorrhage - A Randomized Controlled Trial

Conditions
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Placenta Previa

Intervention / Treatment
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* Drug: Tranexamic acid tablets
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age 28 weeks of gestation. Definite and reliable diagnosis of placenta previa (defined as presence of a placenta within 2 cm of the internal os), using transvaginal ultrasound scan. Haemodynamically stable pregnant women. Maternal age:20-40years old. Pregnant women with placenta previa, and had previous bleeding attacks or admitted with antepartum haemorrhage. Exclusion Criteria: Multiple pregnancy. Women with bleeding tendency due to any medical disorder (ITP, thrombocytopenia, coagulopathies),or on anticoagulants . Severe antepartum hemorrhage and/or hemodynamic instability that necessitates urgent intervention and delivery. Women have hypersensitivity or any contraindication to use of tranexamic acid. Pregnant women with placenta previa with doppler showing morbidly adherent placenta.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pregnant women with symptomatic placenta previa with previous bleeding attacks will be recruited and randomized to receive either tranexamic acid tablets (500mg four times daily) or placebo till delivery. Amount of bleeding during antepartum bleeding attacks will be estimated (by hemoglobin change from baseline at admission till delivery).
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tranexamic acid group<br>100 pregnant women with symptomatic placenta previa with previous bleeding attacks will receive tranexamic acid tablets (500mg four times daily) till delivery. | Drug: Tranexamic acid tablets<br>* Pregnant women with symptomatic placenta previa with previous bleeding attacks will receive tranexamic acid tablets (500mg four times daily) till delivery.<br>* Other names: Kapron(R);|
| Placebo Comparator: Placebo group<br>100 pregnant women with symptomatic placenta previa with previous bleeding attacks will receive placebo tablets four times daily till delivery. | Drug: Placebo oral tablet<br>* Pregnant women with symptomatic placenta previa with previous bleeding attacks will receive placebo tablets four times daily till delivery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of bleeding during antepartum bleeding attacks | Amount of bleeding during antepartum bleeding attacks will be estimated by hemoglobin change from baseline at admission till delivery. | 9 weeks GA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of women requiring antepartum blood transfusion | Number of women requiring antepartum blood transfusion for resuscitation after severe antepartum hemorrhage. | 9 weeks GA | 
| Number of PRBCs units required during antepartum blood transfusion | Number of PRBCs required during antepartum blood transfusion for resuscitation after severe antepartum hemorrhage. | 9 weeks GA | 
| Number of pregnant women experiencing severe antepartum hemorrhage necessitating urgent delivery | Number of pregnant women experiencing severe antepartum hemorrhage necessitating urgent delivery | 9 weeks GA | 
| Gestational age at delivery | Gestational age in weeks at the time of delivery | 9 weeks GA | 
| Neonatal intensive care unit (NICU) admission | Number of neonates requiring NICU admission. | 9 weeks |