An interventional study of ROTEM and standard treatment in Placenta Accreta, sponsored by University of Utah. Completed. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by University of Utah · Not applicable, Interventional, and Diagnostic
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.
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.
150 studies on the registry are indexed under Placenta Accreta; 40 are open to participants now.
This study's enrollment of 32 is below the median of 70 across 67 interventional studies indexed under Placenta Accreta.
Browse Placenta Accreta studies →University of Utah is the lead sponsor of 994 studies on the registry; 175 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 69 (61%) have results posted.
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Exclusion Criteria:
Participants randomized to this arm will have rapid testing of hematocrit and clotting function every 30 minutes during the hysterectomy portion of their surgery for placenta accreta, with transfusion of blood products based on defined abnormalities in these tests.
Procedure: ROTEM
Participants randomized to this arm will have standard visual assessment of blood loss and standard laboratory studies to assess blood count and clotting function when indicated during the hysterectomy portion of their surgery for placenta accreta. Transfusion of blood products will be based on abnormalities of these test results.
Procedure: standard treatment
rapid testing of blood clot formation
visual assessment of blood loss and clotting function every 30 minutes, combined with standard laboratory testing when indicated
Number of units of blood products transfused
Time frame: From the time of surgery up to 10 days, or until discharge from the hospital if this occurs earlier
Number of hours spent in ICU
Time frame: 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
Time frame: 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
Time frame: From the time of surgery up to 10 days, or until discharge from the hospital if this occurs earlier
Readmission for other complications
Time frame: For up to 6 weeks after surgery
No study locations are listed for this record.
Plan to share: No
Ran from May 2016 to primary completion in Dec 2024, 103 months.
Of 45 non-industry interventional studies with no phase under Placenta Accreta, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 41. This study's 103 months is above that.
Counting every sponsor, half of 45 studies reached it within 19 months; a quarter within 12 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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