Bakri Balloon Plus Tranexamic Acid During Cesarean Delivery for Placenta Previa

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Bakri Balloon Tamponade Plus Intravenous Tranexamic Acid During Cesarean Delivery for Placenta Previa: a Randomized Double-blind Controlled Trial

Conditions
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Placenta Previa

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: placebo to TA
* Device: Bakri Balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures Exclusion Criteria: patients with the high possibility of morbid adherent placenta those presented with severe antepartum hemorrhage Patients with cardiac, hepatic, renal, or thromboembolic disease; hypersensitivity or contraindications of use of tranexamic acid patient refuses to consent

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind randomized controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>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 | Drug: Tranexamic Acid<br>* Intravenous 1 gm tranexamic acid in 100 ml saline by slow infusion before skin incision<br>* Other names: TA;Device: Bakri Balloon<br>* 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<br>* Other names: BBT;|
| Active Comparator: control group<br>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 | Drug: placebo to TA<br>* Intravenous 110 ml saline by slow infusion before skin incision<br>* Other names: saline;Device: Bakri Balloon<br>* 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<br>* Other names: BBT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 30minutes |