Topical Tranexamic Acid Plus Bilateral Uterine Artery Ligation During Cesarean Delivery

Study Overview
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Brief Summary
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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. Various conservative measures have been developed to avoid hysterectomy and preserve fertility in patients with PP. Bilateral Uterine artery ligation (BUAL) is one of the reported surgical procedures carried out in these cases as it is easy and quick. It can be used alone or with adjunctive measures with a fair success rate. The aim is to reduce the blood supply to the uterus and to prevent postpartum hemorrhage. 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.

Detailed Description
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Study inclusion criteria will be women undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures Eligible participants were allocated to one of two groups. Group (I): patients managed by bilateral uterine artery ligation (BUAL) after delivery of the fetus which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures. Group (II): patients received 1 gm TA (2 ampoules of Capron® 500 mg /5 ml; Cairo, Egypt) topically applied to the placental bed plus BUA when not respond to uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures.

Official Title
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Topical Tranexamic Acid Plus Bilateral Uterine Artery Ligation During Hemorrhagic Cesarean Delivery for Complete Placenta Previa: a Randomized Double-blind Controlled Trial

Conditions
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Cesarean Section Complications

Intervention / Treatment
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* Procedure: BUA
* Drug: topical tranexamic acid
* Drug: placebo


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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Accepts Healthy Volunteers

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: The current study was a double-blind randomized controlled trial will be conducted at a tertiary University Hospital
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BUAL plus placebo<br>bilateral uterine artery ligation (BUAL) after delivery of the fetus which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures plus 200 ml saline topical application to placental bed | Procedure: BUA<br>* bilateral uterine artery ligation (BUAL) after delivery of the fetus which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures<br>* Other names: Active Comparator;Drug: placebo<br>* topical application of 200ml saline to the placental bed after delivery of the fetus which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures<br>* Other names: Placebo to tranexamic acid;|
| Experimental: BUAL plus topical tranexamic acid<br>bilateral uterine artery ligation (BUAL) after delivery of the fetus which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures plus topical application of 20ml saline contains 2 gm tranexamic acid | Procedure: BUA<br>* bilateral uterine artery ligation (BUAL) after delivery of the fetus which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures<br>* Other names: Active Comparator;Drug: topical tranexamic acid<br>* topical application of 200ml saline contains 2 gm tranexamic acid to the placental bed after delivery of the fetus which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures<br>* Other names: active comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with postpartum hemorrhage | number pf participants with blood loss > 1000ml | 6 hours post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative blood loss | amount of blood loss during cesarean section | during the operation | 
| The number of participant needed for blood transfusion | Calculation of the number of participant needed for blood transfusion | 24 hours post operative | 
| 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 | 24 hours post operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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placenta previa, tranexamic acid, uterine artery ligation