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Purpose to evaluate the effects of topical tranexamic acid (TA) on reducing post-partum hemorrhage in pregnant women with hemorrhagic cesarean section
Uterine atony is the major cause of postpartum hemorrhage (PPH), accounting for up to 80% of PPH cases. PPH is the leading cause of maternal morbidity and mortality worldwide, resulting in up to 28% of maternal deaths. Therefore, inducing a rapid and effective uterine contraction following delivery is an important issue. The aim of the study is to To explore the efficacy and safety of temporary uterine packing combined with topical tranexamic acid (TA) as an adjunct for reducing blood loss during a hemorrhagic cesarean delivery (CD), compared with placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical tranexamic acid | Active Comparator | temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid |
|
| normal saline | Placebo Comparator | temporary uterine packing with gauze of the dimensions soaked with 2 gm placebo to tranexamic diluted in 60ml saline acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical tranexamic acid | Drug | temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of patients need of additional pharmacological uterotonic | calculation number of patients need of additional pharmacological uterotonic | 24 hours post operative |
| Measure | Description | Time Frame |
|---|---|---|
| estimation of intraoperative blood loss (ml) | measure Intraoperative blood loss in ml by gravimetric methods | during the operation |
| amount of postoperative blood loss | measure amount of blood loss post operative in ml by gravimetric methods |
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Inclusion Criteria:
Exclusion Criteria:
placenta praevia and placental abruption
Women with a medical disorder,
placenta accrete,
allergy to TA, and
intraoperative bleeding thanks to causes aside from uterine atony
Patients over 40 or who have
with a severe medical disorder
allergy to tranexamic acid
refuse to consent
patients who were admitted for an elective or non-emergency CS during labor and exposed to intraoperative bleeding about 800 ml
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| Name | Affiliation | Role |
|---|---|---|
| hany f sallam, md | Aswan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aswan University | 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 |
|---|---|
| D014148 | Tranexamic Acid |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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open label Randomized Clinical Tria
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open label Randomized Clinical Tria
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|
| normal saline | Drug | 2 placebo ampoules to TA in 100 ml saline by slow infusion |
|
|
| 4 hours postoperative |
| number of patient with postpartum hemorrhage | calculation of the number of the patients with blood loss >1000 ml | 24 hours post operative |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |