Phase 3
N=110
Tranexamic Acid for Prevention of Hemorrhage in Cesarean Delivery
Post Partum Hemorrhage · Fibrinolysis; Hemorrhage · Blood Loss
Bottom Line
View on ClinicalTrials.gov: NCT03856164 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Blood Volume Loss — 2274; 2407 milliliters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tranexamic Acid (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Jan 2020
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 | — |
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.
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). 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.