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Postpartum hemorrhage and its complications are very well known causes for maternal mortality .Uterine atony is the most common cause for postpartum hemorrhage
Postpartum hemorrhage and its complications are very well known causes for maternal mortality and morbidity especially in developing countries. World Health Organization Recommendations for Active Management of the Third Stage of Labor (AMTSL), on 2012 included the use of uterotonics for the prevention of postpartum hemorrhage (PPH) during the third stage of labor for all births. Tranexamic acid (TA) is antifibrinolytic agent used to decrease blood loss in surgery and health conditions associated with increased bleeding.
A Cochrane Systematic Review from the best available evidence to determine whether TA is effective and safe for preventing PPH in comparison to placebo or no treatment the review concluded that TA (in addition to uterotonic medications) decreases blood loss postpartum and prevents PPH and blood transfusions following vaginal birth and abdominal delivery in women at low risk of PPH based on studies of mixed quality. There was insufficient evidence to draw conclusions about serious side effects and the effects of TA on venous thromboembolic events and mortality beside its use in high-risk women was not investigated on
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic group | Active Comparator | Group A will receive 1gm Tranexamic acide diluted in 20 ML 5% glucose water |
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| Placebo group | Placebo Comparator | Group B will receive 30ML 5% glucose water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid injection | Drug | Participant in group A will receive 2 ampules of 5 milliliters (mL) Tranexamic acid applied to 20 mL of 5% glucose water slowly intravenously immediately after the delivery of the fetus |
| Measure | Description | Time Frame |
|---|---|---|
| The amount of vaginal blood loss in the third and fourth stages (the fourth begins with delivery of the placenta and ends 2 hours after delivery) | The volume of blood loss vaginally will be measured by weighing a specially prepared pad applied beneath the delivered women buttocks before the delivery of the fetus. An electronic scale will be used to weigh the pads before and after 2 hours of the delivery. The quantity of blood (ml) will be = (weight of used materials - weight of materials prior to use) | From the time of injection and up to 2 hours after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participant with Post Partum Hemorrhage | Vaginal blood loss of more than 500 mL | up to 2 hours after delivery |
| Number of participant with severe postpartum hemorrhage | Vaginal blood loss ≥1000mL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shahla K. Alalaf, professor | Hawler Medical University | Principal Investigator |
| Sazgar A. Rashid, FIBOG | Ministery of Health | Study Chair |
| Chro S. Hassan, MBChB | Kurdistan Board for Medical Speciality | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kurdistan Board for Medical speciality | Erbil | Kurdistan Region | 44001 | Iraq | ||
| Maternity Teaching Hospital |
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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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Two infusion bags will be prepared and labeled as bag A (experimental group) containing 1 g/10mL Tranexamic acid diluted with 20mL of 5% glucose water, and bag B (placebo group) containing 30 mL of 5% glucose water. Providers and patients will be blinded to the contents of the bags until the end of the study. TA or placebo will be administered intravenously immediately after the delivery of the fetus.
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All providers and delivered women will be blinded for the content of the bags which will be applied for women randomly
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| Glucose water 5% | Other | Group B will receive 30 mL of 5% glucose water slowly intravenously immediately after the delivery of the fetus |
|
|
| up to 2 hours after delivery |
| Number of participant who will need additional uterotonic drugs to control blood loss | Methyl Ergometrine 0.2 mL, 20 IU oxytocin , and/or 800 misoprostol rectally | up to 2 hours after delivery |
| the mean length of third stage of labor in both groups | time from injection of the intervention and placebo group till the delivery of placenta | up to 30 minutes |
| Erbil |
| Kurdistan Region |
| 44001 |
| Iraq |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |