Phase 3
Completed N=110
Tranexamic Acid for Prevention of Hemorrhage in Cesarean Delivery
Post Partum Hemorrhage · Fibrinolysis; Hemorrhage · Blood Loss
Source: ClinicalTrials.gov NCT03856164 ↗
Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcomePrimary: Blood Volume Loss — 2274; 2407 milliliters
◆ Published Evidence
Emerging
13citations · ~3 / year
Tranexamic acid for prevention of hemorrhage in elective repeat cesarean delivery-a randomized study.
Summary
The investigators prepared a novel study of tranexamic acid (TXA) designed to estimate the quantity of blood loss in women undergoing elective repeat cesarean deliveries. This is the first trial to utilize a prophylactic dose of TXA prior to incision followed by a subsequent prophylactic dose at placental delivery in obstetric patients undergoing scheduled cesareans. The purpose of this study is to quantify blood loss during uncomplicated repeat cesarean deliveries with and without TXA. The central hypothesis is that TXA administration reduces blood loss and fibrinolysis in women undergoing repeat cesarean sections.
Linked Publications
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Tranexamic acid for prevention of hemorrhage in elective repeat cesarean delivery-a randomized study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Volume Loss |
2274; 2407 | — |
| SECONDARY D-Dimer (µg/mL) |
2.9; 4.0; 2.4; 3.8; 2.1; 4.3 | — |
| SECONDARY Fibrinogen (mg/dL) |
563.5; 550.7; 499.6; 484.9; 527.4; 525.4 | — |
| SECONDARY Tissue Plasminogen Activator Antigen (ng/mL) |
8.1; 8.2; 9.0; 9.6; 7.5; 7.4 | — |
| SECONDARY Plasminogen Activator Inhibitor-Type-1 (Units/mL) |
81.8; 61.7; 67.0; 63.3; 20.7; 22.1 | — |
| SECONDARY Rotational Thromboelastometry INTEM and EXTEM Clotting Time |
149.7; 150.5; 137.4; 140.7; 145.1; 141.2 | — |
| SECONDARY Rotational Thromboelastometry INTEM, EXTEM, FIBTEM Maximum Clot Firmness |
69.3; 69.4; 68.9; 68.4; 68.8; 68.8 | — |
Eligibility Criteria
Inclusion Criteria
- Intrauterine pregnancy
- Age ≥ 18
- Gestation age ≥ 37 weeks 0 days
- Scheduled cesarean delivery
- Second or third cesarean delivery
- Singleton pregnancy
Exclusion Criteria
- First cesarean delivery
- Four or more cesarean deliveries
- Intrauterine fetal death
- Fetal anomalies
- Documented coagulopathy (Elevated Prothrombin Time (PT), Elevated Partial Thromboplastin Time (PTT), Elevated International Normalized Ratio (INR))
- Thrombocytopenia (Platelet count 1 mg/dL)
- Insulin-treated diabetes
- Suspected morbidly adherent placenta
- Placenta previa
- Multiple Gestations
- BMI ≥ 50
- Hematocrit ≤ 25
- Blood transfusion within 24 hours prior to cesarean delivery
- History of abnormal bleeding or blood disorder
- Planned general anesthesia
Data sourced from ClinicalTrials.gov (NCT03856164) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.