Hemorrhage
Conditions
Keywords
cesarean delivery, Tranexamic acid, hemorrhage, Spinal analgesia, 1-the amount of hemorrhage during cesarean delivery, 2-the amount of hemorrhage in the first 2 hours of cesarean delivery, 3-the amount of hemorrhage in the first 24 hour after cesarean delivery
Brief summary
Intravenous Tranexamic acid is used to reduce the hemorrhage during and after cesarean delivery in a double blind randomized placebo controlled trial.
Interventions
DRUGTranexamic acid
Tranexamic acid in cases, normal saline in controls
DRUGNormal saline
Tranexamic acid in cases, normal saline in controls
Sponsors
Tehran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
1. Term pregnancy 2. Single fetus 3. Maximally only one previous cesarean delivery
Exclusion criteria
1. More than one previous cesarean delivery 2. Hx of other abdominal or pelvic surgery 3. Hx of medical disorders 4. Hx of thromboembolic disorders 5. Polyhydramnios 6. Macrosomia 7. Preeclampsia 8. Hx of sensitivity to Tranexamic acid 9. Abnormal Pt, PTT, PT or INR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Amount of Hemorrhage During Cesarean Delivery and Within 2 Hours Afterward | During the procedure and within 2 hours afterwards |
Secondary
| Measure | Time frame |
|---|---|
| Amount of Hemorrhage in the First 24 Hour After Cesarean Delivery | First 24 hours |
Countries
Iran
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tranexamic Acid | 50 |
| Normal Saline Infusion | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Normal Saline Infusion | Tranexamic Acid | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 50 Participants | 100 Participants |
| Age Continuous | 27.6 years STANDARD_DEVIATION 4.1 | 27 years STANDARD_DEVIATION 3.4 | 27.3 years STANDARD_DEVIATION 3.7 |
| Region of Enrollment Iran, Islamic Republic of | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 50 Participants | 50 Participants | 100 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
The Amount of Hemorrhage During Cesarean Delivery and Within 2 Hours Afterward
Time frame: During the procedure and within 2 hours afterwards
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tranexamic Acid | The Amount of Hemorrhage During Cesarean Delivery and Within 2 Hours Afterward | 260 ml |
| Normal Saline Infusion | The Amount of Hemorrhage During Cesarean Delivery and Within 2 Hours Afterward | 380 ml |
Secondary
Amount of Hemorrhage in the First 24 Hour After Cesarean Delivery
Time frame: First 24 hours