Phase 4
N=14
Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study
Placenta Accreta · Postpartum Hemorrhage · Cesarean Section · Tranexamic Acid
Bottom Line
View on ClinicalTrials.gov: NCT02806024 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Estimated Blood Loss (EBL) — 3116; 9420 cc
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tranexamic Acid (Drug); Placebo Drug (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of California, San Francisco
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Estimated Blood Loss (EBL) |
3116; 9420 | — |
| SECONDARY Blood Transfusion (Number of Units Transfused) Intraoperatively |
5.2; 17.6 | — |
Summary
The purpose of this pilot study is to determine if intravenous tranexamic acid (TXA) is effective for reducing blood loss during high risk surgical procedures related to placenta previa and placenta accreta. TXA is currently used in other types of surgery for patients who are expected to have a large blood loss, such as orthopedic or open heart surgery.
Eligibility Criteria
Inclusion Criteria
- English and Spanish speaking pregnant women
- Any order pregnancy (singleton, twin gestation, etc)
- Suspected accreta based on ultrasound or MRI imaging studies
- All women evaluated for placenta accreta and deemed to be high risk for this disease (≥40% risk), meaning women diagnosed with a placenta previa and greater than or equal to 2 prior c-sections
Exclusion Criteria
- Women less than 18 years of age
- Women with a personal history of venous or arterial thrombosis (deep vein thrombosis, pulmonary embolism, myocardial infarction, or stroke
- Women with a personal history of a high risk clotting disorder, such as anti-phospholipid syndrome
- Women who do not have a good understanding of either English or Spanish will be excluded.
- Women with defective color vision (color-blindness)
Data sourced from ClinicalTrials.gov (NCT02806024). 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.