Tranexamic Acid and Ethamsylate For Preventing PPH in Patient Undergoing LSCS at High Risk For PPH

Study Overview
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Brief Summary
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The aim of this study is to compare the effect of low dose of Tranexamic acid (1gm) and Ethamsylate (1gm) after prophylactic oxytocin administration versus placebo with prophylactic oxytocin given in the 2 minutes after child delivery in patient undergoing LSCS at high risk for post partum hemorrhage

Detailed Description
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Research Question: Is the combination of Tranexamic acid and Ethamsylate is more effective than oxytocin alone for preventing postpartum hemorrhage if they are given after delivery of the fetus ?

Official Title
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Tranexamic Acid and Ethamsylate For Preventing Post Partum Hemorrhage in Patient Undergoing LSCS at High Risk For Post PartumHemorrhage : A Randomized Controlled Trial

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Drug: Tranexamic Acid and Ethamsylate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women undergoing elective caesarean section Patient having one or more risk factor for PPH Multiple pregnancy Polyhydramnios (AFI >25cm) Macrocosmic baby (>4.5 Kg) Prolonged , augmented and obstructed labour Obese patients(BMI >30) Premature rapture of membranes Previous history of PPH Age ≥18 years Gestational Age ≥ 35 Weeks Informed Oral Consent From The Patient Exclusion Criteria: History of venous thrombosis (DVT and/or Pulmonary embolism) OR arterial thrombosis (angina pectoris , myocardial infarction, stroke) History of epilepsy or seizure Any Known Cardiovascular , renal or liver Disease Autoimmune Diseases Sickle Cell Disease Severe hemorrhagic Disease Placenta Previa. Morbidly adherent Placenta Abruptio placenta Eclampsia, hemolysis, elevated liver enzymes, and low platelet count syndrome Administration Of low molecular weight heparin or Anti platelets the week before delivery .

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tanexamic acid and Ethamsylate<br>10 ml of the study drugs (1 gm Tranexamic acid and 1 gm Ethamsylate ) slowly (over 30-60 sec ) in the 2 minutes after birth | Drug: Tranexamic Acid and Ethamsylate<br>* The intervention will be the intravenous administration of 10 ml blinded vial of the study drugs (either 1 gmTranexamic acid and 1 gm Ethamsylate or placebo according to randomization group) slowly (over 30-60 sec ) in the 2 minutes after birth and the routine prophylactic oxytocin and after the cord has been clamped , all generally by the anesthesiologist or obstetrician then a pad will be placed under women buttocks then weighting the pads to allow objective measurement of blood loss.<br>* Other names: kapron and dycinon;|
| Placebo Comparator: placebo<br>10 ml normal saline will be administered intravenously just after birth | Drug: Tranexamic Acid and Ethamsylate<br>* The intervention will be the intravenous administration of 10 ml blinded vial of the study drugs (either 1 gmTranexamic acid and 1 gm Ethamsylate or placebo according to randomization group) slowly (over 30-60 sec ) in the 2 minutes after birth and the routine prophylactic oxytocin and after the cord has been clamped , all generally by the anesthesiologist or obstetrician then a pad will be placed under women buttocks then weighting the pads to allow objective measurement of blood loss.<br>* Other names: kapron and dycinon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PPH defined as blood loss ≥500 cc | measured by pads placed under women buttocks | the first 24hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severe PPH (>1000 cc), . |  | first 24 hours |