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CompletedNCT02729974ROTEMUpdated Apr 15, 2026

Use of ROTEM Intraoperatively in Women With Placenta Accreta

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

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Placenta Accreta

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Keywords

  • thromboelastography
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In context

Placenta Accreta

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 →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women diagnosed with placenta accreta during pregnancy who are scheduled to have delivery by cesarean section with hysterectomy to follow.

Exclusion criteria

Exclusion Criteria:

  • Non-English speaking
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Enrollment
32 participants (actual)

Study arms

  • Experimental
    ROTEM

    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

  • Active comparator
    Standard treatment

    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

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

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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Readmission for other complications

    Time frame: For up to 6 weeks after surgery

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Wortman AC, Alexander JM. Placenta accreta, increta, and percreta. Obstet Gynecol Clin North Am. 2013 Mar;40(1):137-54. doi: 10.1016/j.ogc.2012.12.002. PubMed 23466142 ↗
  • Upson K, Silver RM, Greene R, Lutomski J, Holt VL. Placenta accreta and maternal morbidity in the Republic of Ireland, 2005-2010. J Matern Fetal Neonatal Med. 2014 Jan;27(1):24-9. doi: 10.3109/14767058.2013.799654. Epub 2013 May 30. PubMed 23638753 ↗
  • Eller AG, Bennett MA, Sharshiner M, Masheter C, Soisson AP, Dodson M, Silver RM. Maternal morbidity in cases of placenta accreta managed by a multidisciplinary care team compared with standard obstetric care. Obstet Gynecol. 2011 Feb;117(2 Pt 1):331-337. doi: 10.1097/AOG.0b013e3182051db2. PubMed 21309195 ↗
  • Meyer AS, Meyer MA, Sorensen AM, Rasmussen LS, Hansen MB, Holcomb JB, Cotton BA, Wade CE, Ostrowski SR, Johansson PI. Thrombelastography and rotational thromboelastometry early amplitudes in 182 trauma patients with clinical suspicion of severe injury. J Trauma Acute Care Surg. 2014 Mar;76(3):682-90. doi: 10.1097/TA.0000000000000134. PubMed 24553534 ↗
  • Brazzel C. Thromboelastography-guided transfusion Therapy in the trauma patient. AANA J. 2013 Apr;81(2):127-32. PubMed 23971232 ↗
  • Rourke C, Curry N, Khan S, Taylor R, Raza I, Davenport R, Stanworth S, Brohi K. Fibrinogen levels during trauma hemorrhage, response to replacement therapy, and association with patient outcomes. J Thromb Haemost. 2012 Jul;10(7):1342-51. doi: 10.1111/j.1538-7836.2012.04752.x. PubMed 22519961 ↗
  • Huissoud C, Carrabin N, Audibert F, Levrat A, Massignon D, Berland M, Rudigoz RC. Bedside assessment of fibrinogen level in postpartum haemorrhage by thrombelastometry. BJOG. 2009 Jul;116(8):1097-102. doi: 10.1111/j.1471-0528.2009.02187.x. Epub 2009 May 12. PubMed 19459866 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

Registered
Mar 18, 2016
First posted
Apr 6, 2016
StartActual
May 8, 2016
Primary completionActual
Dec 2024
CompletionActual
Dec 2025
Last update
Apr 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02729974
Lead sponsor
University of Utah
Responsible party
Brett Einerson (Principal Investigator, University of Utah) — Principal investigator
First posted
Apr 6, 2016
Start date
May 8, 2016
Primary completion
Dec 2024
Completion
Dec 2025
Last update
Apr 15, 2026

Study contacts

Heather Campbell, MD
principal investigator · University of Utah, Department of OBGYN

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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