Pregnant Women Undergoing Cesarean Delivery
Conditions
Keywords
tranexamic acid, blood loss, pregnant women, cesarean delivery
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
Interventions
DRUGTranexamic Acid
Tranexamic Acid 1 g intravenous preoperation
OTHERPlacebo
normal saline 20 ml intravenous preoperation
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood loss | From enrollment to the end of operation | blood loss in ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| early postpartum hemorrhage | From starting operation to 24-hour postoperation | percentage of early postpartum hemorrhage |
| delayed postpartum hemorrhage | From starting operation to 6 weeks postpartum | percentage of delayed postpartum hemorrhage |
| Adverse effects | from enrollment to 6 weeks postpartum | percentage of adverse effects |
| Neonatal outcomes | from starting operation to 10 minutes after birth | Apgar scores (0 is the minimum value and 10 is maximum value, and higher scores mean a better outcome) |
Countries
Thailand
Contacts
Primary ContactVorapong Phupong, M.D.
Backup ContactThawit Suesakulpaisal, M.D.
Outcome results
None listed