Combined Bilateral Uterine Artery Ligation and Bakri Balloon During Cesarean Section

Study Overview
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Brief Summary
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This study will be performed to compare the effectiveness of routine Bakri balloon tamponade and Bilateral Uterine Artery Ligation during cesarean section in patients with placenta previa

Detailed Description
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Intraoperative methods to control profuse bleeding during cesarean section in patients with placenta previa include uterine packing, balloon tamponade, uterine compression sutures, arterial ligation, uterine artery embolization, and hysterectomy.

Official Title
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Clinical Outcomes of Combined Bilateral Uterine Artery Ligation and Bakri Balloon Tamponade During Cesarean Section in Patients With Placenta Previa: a Randomized Controlled Trial

Conditions
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Placenta Previa

Intervention / Treatment
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* Device: Bakri balloon
* Procedure: Bilateral Uterine Artery Ligation


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; 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: A Randomized Controlled Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>patients with placenta previa undergoing cesarean section underwent bilateral uterine artery ligation plus insertion of Bakri balloon | Device: Bakri balloon<br>* the 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;Procedure: Bilateral Uterine Artery Ligation<br>* The peritoneum over the vesico-uterine pouch already being incised horizontally, the peritoneum over the uterine isthmus and cervix was dissected downwards, and this dissection was then extended laterally.<br>* Other names: BUAL;|
| Active Comparator: control group<br>patients with placenta previa undergoing cesarean section underwent insertion of Bakri balloon | Device: Bakri balloon<br>* the 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 |
| --- | --- | --- |
| The number of participant needed for blood transfusion | Calculation of the number of participant needed for blood transfusion | 24 hours | 
| Number of Participants with postpartum hemorrhage | number pf participants with blood loss > 1000ml | 24 hours |