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Completed

NCT Number: NCT02729974

Use of ROTEM Intraoperatively in Women With Placenta Accreta

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.

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Key information

Conditions

Placenta Accreta Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Placenta Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ROTEM

Procedure

rapid testing of blood clot formation

Standard treatment

Procedure

visual assessment of blood loss and clotting function every 30 minutes, combined with standard laboratory testing when indicated

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

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Acronym: ROTEM

Important dates

Study start
2016
Primary completion
2024
Study completion
2025
First posted
Apr 6, 2016
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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