Comparison Study of Oxytocin Versus Tranexamic Acid and Etamsylaye Versus Placebo(Saline)

Study Overview
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Brief Summary
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Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Normal Saline as Pre-operative Administration.

Detailed Description
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Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Normal Saline to reduce intra operative bleeding and postoperative bleeding during elective Cesarean Delivery.

Official Title
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Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Placebo to Reduce Blood Loss Intraoperative and Post Operative During Elective Cesarean Section

Conditions
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Blood Loss, Surgical, Blood Loss, Postoperative

Intervention / Treatment
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* Drug: Oxytocin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant females admitted for Elective Cesarean Section. Gestational age of pregnancy (38 weeks To 40 weeks). the average height of 145 to 160 cm,average body weight of 45 to 85 kgs. Singleton living fetus. No medical disorders. Informed Oral Consent From The Patient. Exclusion Criteria: Severe medical and surgical disorders as thyroid dysfunction, which was excluded by routine thyroid function test (free T3, free T4, and thyroid stimulating hormone(TSH), all of them should be within normal limits). Bleeding tendency, for example, disseminated intravascular coagulopathy, which was excluded by platelet count, coagulation time, bleeding time, prothrombin time, partial thromboplastin time, and thrombin time (all should be within normal). Acute liver or kidney diseases; blood disorders, such as anaemia. Allergy to Tranexamic acid. Risk factors for PPH, such as polyhydramnios, fetal macrosomia, antepartum haemorrhage. Ante partum Hemorrhage such placental abruption.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxytocin<br>Pre- Operative Oxytocin is given intravenously 5-10 minutes slowly before skin incision | Drug: Oxytocin<br>* trial of reduction of losing blood intra operative or post operative during Cesarean Delivery<br>* Other names: Tranexamic acid and Etamsylate;|
| Active Comparator: Tranexamic acid and Etamsylate<br>Tranexamic acid and Etamsylate are slowly given intravenously 10 minutes before start of Cesarean Delivery | Drug: Oxytocin<br>* trial of reduction of losing blood intra operative or post operative during Cesarean Delivery<br>* Other names: Tranexamic acid and Etamsylate;|
| Placebo Comparator: Saline<br>Normal saline (about 200 ml) is given intravenously 10 minutes before start of Cesarean Section | Drug: Oxytocin<br>* trial of reduction of losing blood intra operative or post operative during Cesarean Delivery<br>* Other names: Tranexamic acid and Etamsylate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood loss during and after cesarean delivery | Measuring of Hemoglobin level and Hematocrit level pre and post operatively. | First 2 hours after C-Section | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post operative bleeding | assessment of Hemoglobin level and Hematocrit level post operatively. | first 24 hours after C-Section | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood loss, cesarean section, oxytocin, tranexamic acid, etamsylate, saline, Intra-operative, Postoperative