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| ID | Type | Description | Link |
|---|---|---|---|
| COA 0685/2025 | Other Identifier | Chulalongkorn University |
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The purpose of this study is to asses the effect of preoperative prophylactic intravenous tranexamic acid on perioperative blood loss in pregnant women undergoing cesarean section
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic acid | Active Comparator | Tranexamic acid (1 g) 20 ml intravenous preoperation |
|
| Placebo | Placebo Comparator | Normal saline 20 ml intravenous preoperation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | Tranexamic Acid 1 g intravenous preoperation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Blood loss | blood loss in ml | From enrollment to the end of operation |
| Measure | Description | Time Frame |
|---|---|---|
| early postpartum hemorrhage | percentage of early postpartum hemorrhage | From starting operation to 24-hour postoperation |
| delayed postpartum hemorrhage | percentage of delayed postpartum hemorrhage |
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Inclusion Criteria:
Exclusion Criteria:
pregnant women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vorapong Phupong, M.D. | Contact | +6626492115 | vorapong.p@chula.ac.th | |
| Thawit Suesakulpaisal, M.D. | Contact | 026492115 | tsm.2539@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Vorapong Phupong, M.D. | Chulalongkorn University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University | Bangkok | Bangkok | 10330 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33913639 | Background | Sentilhes L, Senat MV, Le Lous M, Winer N, Rozenberg P, Kayem G, Verspyck E, Fuchs F, Azria E, Gallot D, Korb D, Desbriere R, Le Ray C, Chauleur C, de Marcillac F, Perrotin F, Parant O, Salomon LJ, Gauchotte E, Bretelle F, Sananes N, Bohec C, Mottet N, Legendre G, Letouzey V, Haddad B, Vardon D, Madar H, Mattuizzi A, Daniel V, Regueme S, Roussillon C, Benard A, Georget A, Darsonval A, Deneux-Tharaux C; Groupe de Recherche en Obstetrique et Gynecologie. Tranexamic Acid for the Prevention of Blood Loss after Cesarean Delivery. N Engl J Med. 2021 Apr 29;384(17):1623-1634. doi: 10.1056/NEJMoa2028788. | |
| 37043652 |
| Label | URL |
|---|---|
| Related Info | View source |
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Waiting for the permission from IRB
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |
| Other |
normal saline 20 ml intravenous preoperation |
|
| From starting operation to 6 weeks postpartum |
| Adverse effects | percentage of adverse effects | from enrollment to 6 weeks postpartum |
| Neonatal outcomes | Apgar scores (0 is the minimum value and 10 is maximum value, and higher scores mean a better outcome) | from starting operation to 10 minutes after birth |
| Background |
| Pacheco LD, Clifton RG, Saade GR, Weiner SJ, Parry S, Thorp JM Jr, Longo M, Salazar A, Dalton W, Tita ATN, Gyamfi-Bannerman C, Chauhan SP, Metz TD, Rood K, Rouse DJ, Bailit JL, Grobman WA, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Tranexamic Acid to Prevent Obstetrical Hemorrhage after Cesarean Delivery. N Engl J Med. 2023 Apr 13;388(15):1365-1375. doi: 10.1056/NEJMoa2207419. |
| 37311484 | Background | Cheema HA, Ahmad AB, Ehsan M, Shahid A, Ayyan M, Azeem S, Hussain A, Shahid A, Nashwan AJ, Mikus M, Lagana AS. Tranexamic acid for the prevention of blood loss after cesarean section: an updated systematic review and meta-analysis of randomized controlled trials. Am J Obstet Gynecol MFM. 2023 Aug;5(8):101049. doi: 10.1016/j.ajogmf.2023.101049. Epub 2023 Jun 11. |
| 37216058 | Background | Angolile CM, Max BL, Mushemba J, Mashauri HL. Global increased cesarean section rates and public health implications: A call to action. Health Sci Rep. 2023 May 18;6(5):e1274. doi: 10.1002/hsr2.1274. eCollection 2023 May. |
| Related Info | View source |