Prophylactic Intravenous Tranexamic Acid on Perioperative Blood Loss in Pregnant Women Undergoing Cesarean Section
NCT ID: NCT07078942
Last Updated: 2025-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
98 participants
INTERVENTIONAL
2025-07-20
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Tranexamic acid
Tranexamic acid (1 g) 20 ml intravenous preoperation
Tranexamic Acid
Tranexamic Acid 1 g intravenous preoperation
Placebo
Normal saline 20 ml intravenous preoperation
Placebo
normal saline 20 ml intravenous preoperation
Interventions
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Tranexamic Acid
Tranexamic Acid 1 g intravenous preoperation
Placebo
normal saline 20 ml intravenous preoperation
Eligibility Criteria
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Inclusion Criteria
* undergoing cesarean delivery with indication as follows: placenta previa, severe preeclampsia, myoma uteri, fetal macrosomia, polyhydramnios, grand multiparity ≥ 5 deliveries, prolonged labor, etc.
Exclusion Criteria
* history of venous thromboembolism (Deep vein thrombosis, Pulmonary embolism)
* history of arterial thrombosis (Myocardial infarction, Stroke)
* history of seizure, convulsion
* have underlying of cardiovascular, renal or liver disease
* using of antiplatelet or anticoagulant within 1 week before operation
* placenta accreta spectrum
* abruptio placenta
* Eclampsia or HELLP (Hemolysis Elevated Liver Low Platelet) syndrome
* Failed operative vaginal delivery
* Multifetal gestation
18 Years
FEMALE
Yes
Sponsors
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Chulalongkorn University
OTHER
Responsible Party
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Vorapong Phupong
Professor
Principal Investigators
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Vorapong Phupong, M.D.
Role: STUDY_DIRECTOR
Chulalongkorn University
Locations
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Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University
Bangkok, Bangkok, Thailand
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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 Links
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Other Identifiers
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COA 0685/2025
Identifier Type: OTHER
Identifier Source: secondary_id
0127/68
Identifier Type: -
Identifier Source: org_study_id
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