Prophylactic Intravenous Tranexamic Acid on Perioperative Blood Loss in Pregnant Women Undergoing Cesarean Section
Effect of Preoperative Prophylactic Intravenous Tranexamic Acid on Perioperative Blood Loss in Pregnant Women Undergoing Cesarean Section : A Randomized Controlled Trial
2 other identifiers
interventional
98
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2025
CompletedStudy Start
First participant enrolled
July 20, 2025
CompletedFirst Posted
Study publicly available on registry
July 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedJuly 28, 2025
July 1, 2025
1 year
July 14, 2025
July 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood loss
blood loss in ml
From enrollment to the end of operation
Secondary Outcomes (4)
early postpartum hemorrhage
From starting operation to 24-hour postoperation
delayed postpartum hemorrhage
From starting operation to 6 weeks postpartum
Adverse effects
from enrollment to 6 weeks postpartum
Neonatal outcomes
from starting operation to 10 minutes after birth
Study Arms (2)
Tranexamic acid
ACTIVE COMPARATORTranexamic acid (1 g) 20 ml intravenous preoperation
Placebo
PLACEBO COMPARATORNormal saline 20 ml intravenous preoperation
Interventions
Eligibility Criteria
You may qualify if:
- pregnant women with gestational age 37-42 weeks
- undergoing cesarean delivery with indication as follows: placenta previa, severe preeclampsia, myoma uteri, fetal macrosomia, polyhydramnios, grand multiparity ≥ 5 deliveries, prolonged labor, etc.
You may not qualify if:
- history of allergy to tranexamic acid
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University
Bangkok, Bangkok, 10330, Thailand
Related Publications (4)
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.
PMID: 33913639BACKGROUNDPacheco 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.
PMID: 37043652BACKGROUNDCheema 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.
PMID: 37311484BACKGROUNDAngolile 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.
PMID: 37216058BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Vorapong Phupong, M.D.
Chulalongkorn University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 14, 2025
First Posted
July 22, 2025
Study Start
July 20, 2025
Primary Completion
July 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
July 28, 2025
Record last verified: 2025-07