Not yet recruiting NCT07078942
Prophylactic Intravenous Tranexamic Acid on Perioperative Blood Loss in Pregnant Women Undergoing Cesarean Section
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tranexamic Acid, Placebo.
- Who it may be relevant to
- Registry conditions: Pregnant Women Undergoing Cesarean Delivery. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Preoperative Prophylactic Intravenous Tranexamic Acid on Perioperative Blood Loss in Pregnant Women Undergoing Cesarean Section : A Randomized Controlled Trial
Overview
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
Interventions
- Drug Tranexamic Acid
Tranexamic Acid 1 g intravenous preoperation - Other Placebo
normal saline 20 ml intravenous preoperation
Primary outcome measures
- Blood loss [Time frame: From enrollment to the end of operation]
Secondary outcome measures (4)
- early postpartum hemorrhage [Time frame: From starting operation to 24-hour postoperation]
- delayed postpartum hemorrhage [Time frame: From starting operation to 6 weeks postpartum]
- Adverse effects [Time frame: from enrollment to 6 weeks postpartum]
- Neonatal outcomes [Time frame: from starting operation to 10 minutes after birth]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Thailand · 1 center
- Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University — Bangkok
Publications
- 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-Thara PMID 33913639
- 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 Deli PMID 37043652
- 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. PMID 37311484
- 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. PMID 37216058
Identifiers
NCT: NCT07078942 · 0127/68 · COA 0685/2025