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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
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 ?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tanexamic acid and Ethamsylate | Experimental | 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 |
|
| placebo | Placebo Comparator | 10 ml normal saline will be administered intravenously just after birth |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid and Ethamsylate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PPH defined as blood loss ≥500 cc | measured by pads placed under women buttocks | the first 24hours |
| Measure | Description | Time Frame |
|---|---|---|
| severe PPH (>1000 cc), . | first 24 hours |
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Inclusion Criteria:
Women undergoing elective caesarean section
Patient having one or more risk factor for PPH
Age ≥18 years
Gestational Age ≥ 35 Weeks
Informed Oral Consent From The Patient
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ahmed Dr alanwar, MD | Contact | +201111486669 | 0020 | eladwar@hotmail.com |
| ahmed Dr kotb, MD | Contact | +201008681999 | 0020 | ahmedmkotp@hotmail.com |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D004979 | Ethamsylate |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
|
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001557 |
| Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |