Placenta Accreta
Conditions
Keywords
thromboelastography
Brief summary
This study evaluates the use of rapid tests for hematocrit and clotting function in women undergoing surgery for placenta accreta. Half of participants will have these rapid tests performed during surgery to guide blood product transfusion and the other half will have standard lab tests performed to guide transfusion.
Detailed description
Placenta accreta has become an increasingly common pregnancy complication. Serious complications are common in patients with placenta accreta, including hemorrhage, transfusion of blood products, abdominal organ injury, bladder surgery, and ICU admission. Hemorrhage, or excessive blood loss, is the most common complication and often results in impaired ability for the body to form blood clots normally. The development of rapid testing of hematocrit and clotting function may allow for earlier identification of patients who have severe blood loss and development of clotting abnormalities. The investigators are testing whether use of this technology in patients undergoing surgery for placenta accreta, with earlier identification of patients with severe blood loss or clotting abnormality, will result in a lower need for transfusion and fewer complications.
Interventions
PROCEDUREROTEM
rapid testing of blood clot formation
PROCEDUREstandard treatment
visual assessment of blood loss and clotting function every 30 minutes, combined with standard laboratory testing when indicated
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Women diagnosed with placenta accreta during pregnancy who are scheduled to have delivery by cesarean section with hysterectomy to follow.
Exclusion criteria
* Non-English speaking
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of units of blood products transfused | From the time of surgery up to 10 days, or until discharge from the hospital if this occurs earlier |
Secondary
| Measure | Time frame |
|---|---|
| Number of hours spent in ICU | From the time of surgery up to 10 days, or until discharge from the hospital if this occurs earlier |
| Number of days in the hospital | From the time of surgery up to 10 days, or until discharge from the hospital if this occurs earlier |
| Presence of infection at the surgery site | From the time of surgery up to 10 days, or until discharge from the hospital if this occurs earlier |
| Readmission for other complications | For up to 6 weeks after surgery |
Outcome results
None listed