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Postpartum hemorrhage continues to be the leading cause of maternal morbidity and mortality. Globally, it is responsible for 25% of all pregnancy-related deaths. PPH is unpredictable and may occur in the absence of risk factors. Tranexamic acid is an antifibrinolytic proven to reduce blood loss and transfusion requirements for various surgeries. This study aims to explore the effectiveness of tranexamic acid as an adjunct to other uterotonics before the Caesarian Section.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | All women recruited to Group A will receive tranexamic acid 1 gram in 100 ml Normal Saline as intravenous infusion 10 minutes before the skin incision. |
|
| Group B | Placebo Comparator | All women recruited to Group A will receive 100 ml Normal Saline as intravenous infusion 10 minutes before the skin incision, as placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid injection | Drug | All women recruited to Group A will receive tranexamic acid 1 gram in 100 ml Normal Saline as intravenous infusion 10 minutes before the skin incision. |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative blood loss | The primary aim of the trial is to investigate the effect of tranexamic acid on peri and post- operative blood loss during caesarean section | Amount of blood loss from starting from surgical incision till 24 hours post caesarean section. |
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Inclusion Criteria:
Exclusion Criteria:
Women posted for elective or emergency caesarean section.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MUAZZAM HASAN, MD | Contact | 9808447427 | MUAZZAMSH@GMAIL.COM |
| Name | Affiliation | Role |
|---|---|---|
| MUAZZAM HASAN, MD | AMU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASJSATDS Medical College | Recruiting | Fatehpur | Uttar Pradesh | 212601 | India |
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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 |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo | Drug | All women recruited to Group B will receive 100 ml Normal Saline as intravenous infusion 10 minutes before the skin incision. |
|
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |