Use of ROTEM Intraoperatively in Women With Placenta Accreta (ROTEM)

April 12, 2026 updated by: Brett Einerson, University of Utah
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
rapid testing of blood clot formation
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
visual assessment of blood loss and clotting function every 30 minutes, combined with standard laboratory testing when indicated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From the time of surgery up to 10 days, or until discharge from the hospital if this occurs earlier

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
For up to 6 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Investigators

  • Principal Investigator: Heather Campbell, MD, University of Utah, Department of OBGYN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2016

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

December 1, 2025

Study Registration Dates

First Submitted

March 18, 2016

First Submitted That Met QC Criteria

March 31, 2016

First Posted (Estimated)

April 6, 2016

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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