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Objective to investigate the effect of adjunctive intravenous tranexamic acid (TA) on blood loss during cesarean section (CS) in patients with placenta previa undergone Bakri balloon tamponade
Placenta previa (PP) is an obstetric condition that is closely linked with massive obstetric hemorrhage with a varied incidence about once in every 200 live births. It is considered one of the causes of the increased need for blood transfusion and cesarean hysterectomy. PPH due to PP typically starts during cesarean section (CS) in the placental bed, at the lower uterine segment mostly after placental separation. Proceeding for cesarean hysterectomy can be the only effective line of management in spite of the associated high morbidity rate.
Tranexamic acid is a lysine analog which acts as an antifibrinolytic via competitive inhibition of the binding of plasmin and plasminogen to fibrin. The rationale for its use in the reduction of blood loss depending on the implication of the coagulation and fibrinolysis processes implicated in the control of PPH. However, concerns about possible thromboembolic events with parenteral administration of TA have stimulated increasing interest in its topical use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Experimental | Bakri balloon was inserted into the lower uterine segment through the uterine incision by passing the balloon shaft through the cervix with an assistant pulling vaginally plus 1gm tranexamic acid by intravenous infusion |
|
| control group | Active Comparator | Bakri balloon was inserted into the lower uterine segment through the uterine incision by passing the balloon shaft through the cervix with an assistant pulling vaginally plus saline by intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | Intravenous 1 gm tranexamic acid in 100 ml saline by slow infusion before skin incision |
|
| Measure | Description | Time Frame |
|---|---|---|
| mean Blood loss after placental separation | by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with postpartum hemorrhage | number pf participants with blood loss > 1000ml | 12 hours |
| The number of participant needed of extra surgical maneuvers | Calculation of the number of participant needed of extra surgical maneuvers like internal iliac artery ligation |
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Inclusion Criteria:
Exclusion Criteria:
women undergoing elective cesarean delivery for complete placenta previa
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| hany f Sallam, md | Contact | +20102435461 | 002 | hany.farouk@aswu.edu.eg |
| nahla w Shady, md | Contact | +201022336052 | 002 | hanygyne@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| nahla w Shady, md | Aswan universirty | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aswan University Hospital | Recruiting | Aswān | 81528 | 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 |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Double blind randomized controlled trial
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Double blind randomized controlled trial
| placebo to TA | Drug | Intravenous 110 ml saline by slow infusion before skin incision |
|
|
| Bakri Balloon | Device | Bakri balloon was inserted into the lower uterine segment through the uterine incision by passing the balloon shaft through the cervix with an assistant pulling vaginally |
|
|
| 30minutes |
| D010922 | Placenta Diseases |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |