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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic acid group | Active Comparator | 100 pregnant women with symptomatic placenta previa with previous bleeding attacks will receive tranexamic acid tablets (500mg four times daily) till delivery. |
|
| Placebo group | Placebo Comparator | 100 pregnant women with symptomatic placenta previa with previous bleeding attacks will receive placebo tablets four times daily till delivery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid tablets | Drug | Pregnant women with symptomatic placenta previa with previous bleeding attacks will receive tranexamic acid tablets (500mg four times daily) till delivery. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amal Ramadan, MBBCh | Contact | +201098093525 | dr.amalramadan11@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Amal Ramadan, MBBCh | A Ramadan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain SHams Maternity Hospital | Recruiting | Cairo | Abbaseya | 002 | Egypt |
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| ID | Term |
|---|---|
| D010923 | Placenta Previa |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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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).
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Visually-identical drug and placebo tablets will be assigned to each participant using SNOSE congaing assignment code.
|
| Placebo oral tablet | Drug | Pregnant women with symptomatic placenta previa with previous bleeding attacks will receive placebo tablets four times daily till delivery. |
|
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 |
| D010922 | Placenta Diseases |