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Purpose to evaluates the effects of sublingual misoprostol with or without intravenous tranexamic acid (TA) on reducing post-partum hemorrhage during and after hemorrhagic cesarean section.
Different uterotonic agents administration, mainly oxytocin, has been routinely used to reduce the frequency of cesarean section (CS) -related hemorrhage; however, some studies reported that oxytocin use in the setting of CS may result in maternal adverse effects, including hypotension and tachycardia., Therefore, investigating other therapeutic agents with lower adverse effects and higher efficacy is needed. Recently, a number of studies reported a correlation between fibrinogen decrease and cesarean-related hemorrhage. Furthermore, extensive tissue injury increases fibrinolysis by shifting the hemostatic equilibrium and contributing to bleeding. Therefore, anti-fibrinolytic agents, such as tranexamic acid (TA), reduce the risk of death in bleeding trauma patients. On the other hand, it has been suggested that TA administration reduces blood loss and the incidence of postpartum hemorrhage (PPH) in females after vaginal or elective CS verse effects and higher efficacy is needed. Moreover, misoprostol is a prostaglandin E1 analog which has been introduced as a uterotonic agent for preventing PPH following CS. A recent study reported that oral or sublingual misoprostol is more effective than the placebo in reducing severe PPH, following CS
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Misoprostol with TA | Active Comparator | two tablets sublingual misoprostol plus IgM tranexamic acid in 100 ml saline by slow iv |
|
| Misoprostol with placebo to TA | Active Comparator | two tablets sublingual misoprostol plus placebo to tranexamic acid ( 110 ml saline) by slow iv |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | two tablets misoprostol 400 μg sublingual |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of patients develop postpartum hemorrhage | calculation of number of patients develop postpartum hemorrhage | 6 hours post operative |
| Measure | Description | Time Frame |
|---|---|---|
| intraoperative blood loss (ml) | calculation of the amount of blood loss in ml by gravimetric methods | during the operation |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative blood loss (ml) | calculation of the amount of blood loss in ml by gravimetric methods | 6 hours post operative |
| number of patients need blood transfusion | calculation of number of patients need blood transfusion |
Inclusion Criteria:
Exclusion Criteria:
women who undergo elective cesarean section (C.S) and exposed to intraoperative bleeding about 500 ml diagnosed by visual analog estimation due to atonic uterus
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| hany f sallam | Contact | 01022336052 | 002 | hany.farouk@aswu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| hany f sallam, md | Aswan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aswan University | Recruiting | Aswān | 81528 | Egypt |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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double-blind placebo randomized controlled trial
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The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which will be used
| Tranexamic Acid | Drug | two ampoules of tranexamic acid (1gm in 10 ml) in 100ml saline |
|
|
| placebo to tranexamic acid | Drug | placebo to tranexamic acid (110 ml saline) |
|
|
| 24 hours postoperative |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |