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The aim of the study is to evaluate the effect of oral tranexamic acid plus, sublingual misoprostol in the management of atonic postpartum hemorrhage (PPH) after vaginal delivery
Uterine atony is the main cause of PPH; therefore, active management of the third stage of labor has emerged as a most actual tool in its prevention. The previous study in Egypt recorded that 88% of deaths from PPH occur within 4 h of delivery. Tranexamic acid (TA) is an antifibrinolytic agent that blocks the lysine-binding site of plasminogen to fibrin. Accordingly, clot breaks down, fibrinolysis is inhibited, and excessive bleeding is reduced. In previous studies, its safety has been confirmed for use in non-pregnant women, with no thromboembolic complications. TA is an inexpensive, widely available medicine that has been shown to reduce bleeding in surgery and reduce the risk of death in bleeding trauma patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TA plus misoprostol | Active Comparator | Patient receive 600mic gm sublingual misoprostol plus oral tranexamic acid 1 gm |
|
| Carbetocin | Active Comparator | Patient receives 100 mic gm carbetocin IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| misoprostol | Drug | Patient receive 600mic gm sublingual misoprostol |
|
| Measure | Description | Time Frame |
|---|---|---|
| the amount of blood loss | the amount of blood loss by gm calculated by gravimetric methods | 6 hours post delivery |
| Measure | Description | Time Frame |
|---|---|---|
| number of patients loss more than 1000 ml blood | calculate number of patients loss more than 1000 ml blood | 24 hours post delivery |
| need of uterotonics | number of patients need of uterotonics |
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Inclusion Criteria:
Exclusion Criteria:
All participants had PPH defined as vaginal bleeding>500 ml after vaginal delivery and uterine atony confirmed by abdominal palpation.
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| Name | Affiliation | Role |
|---|---|---|
| hany f allam, md | Aswan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AswanUH | Aswān | 81528 | Egypt |
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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 |
|---|---|
| D016595 | Misoprostol |
| C020731 | carbetocin |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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This study was a prospective double-blind randomized study
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This study was a prospective double-blind randomized study
| Carbetocin | Drug | Patient receive 100 mic gm carbetocin IV |
|
|
| TA | Drug | The patient receives 1gm oral tranexamic acid |
|
|
| 24 hours post delivery |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |