Placenta AccretaROTEMNCT02729974
Use of ROTEM Intraoperatively in Women With Placenta Accreta
A study testing ROTEM and standard treatment in people with Placenta Accreta, run by University of Utah.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- ROTEM and standard treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 8 May 2016to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women diagnosed with placenta accreta during pregnancy who are scheduled to have delivery by cesarean section with hysterectomy to follow.
Who cannot join
- Non-English speaking
About this study
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.
- Conditions
- Placenta Accreta
- Being tested
- ROTEM, standard treatment
- Keywords
- thromboelastography
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROTEMProcedure or surgery
rapid testing of blood clot formation
standard treatmentProcedure or surgery
visual assessment of blood loss and clotting function every 30 minutes, combined with standard laboratory testing when indicated
| Study group | Role | What they receive |
|---|---|---|
| ROTEM | Experimental | 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. Receives: Procedure: ROTEM |
| Standard treatment | Active comparator | 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. Receives: Procedure: standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of units of blood products transfused
Measured: From the time of surgery up to 10 days, or until discharge from the hospital if this occurs earlier
Secondary outcomes (4)
Number of hours spent in ICU
Measured: 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
Measured: 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
Measured: From the time of surgery up to 10 days, or until discharge from the hospital if this occurs earlier
Readmission for other complications
Measured: For up to 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study start8 May 2016
- Primary completionDec 2024
- Study completionDec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Placenta AccretaStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brett Einerson, University of Utah
- Investigators
- Heather Campbell, MD, Principal investigator, University of Utah, Department of OBGYN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02729974
- Sponsor's protocol ID
- 81113
- Acronym
- ROTEM
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2016
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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 23466142Upson 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 23638753Eller 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 21309195Meyer 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 24553534Brazzel C. Thromboelastography-guided transfusion Therapy in the trauma patient. AANA J. 2013 Apr;81(2):127-32.
PubMed 23971232Rourke 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 22519961Huissoud 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of ROTEM Intraoperatively in Women With Placenta Accreta
- ClinicalTrials.gov ID
- NCT02729974
- Acronym / sponsor ID
- ROTEM / 81113
- Conditions
- Placenta Accreta
- Keywords
- thromboelastography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 8 May 2016 (actual)
- Primary completion
- Dec 2024 (actual)
- Study completion
- Dec 2025 (actual)
- First posted
- 6 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ROTEM | Experimental | Procedure: ROTEMParticipants 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. |
| Standard treatment | Active comparator | Procedure: standard treatmentParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women diagnosed with placenta accreta during pregnancy who are scheduled to have delivery by cesarean section with hysterectomy to follow.
Key exclusion criteria (1 listed)
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROTEMrapid testing of blood clot formation | Procedure or surgery | ROTEM |
| standard treatmentvisual assessment of blood loss and clotting function every 30 minutes, combined with standard laboratory testing when indicated | Procedure or surgery | Standard treatment |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Background: PubMed 23466142Wortman 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.
- Background: PubMed 23638753Upson 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.
- Background: PubMed 21309195Eller 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.
- Background: PubMed 24553534Meyer 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.
- Background: PubMed 23971232Brazzel C. Thromboelastography-guided transfusion Therapy in the trauma patient. AANA J. 2013 Apr;81(2):127-32.
- Background: PubMed 22519961Rourke 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.
- Background: PubMed 19459866Huissoud 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Campbell, MD principal investigator
University of Utah, Department of OBGYN
Questions about this trial
What is this clinical trial studying?
A study testing ROTEM and standard treatment in people with Placenta Accreta, run by University of Utah.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02729974, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.