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OpenTrials
Completed

NCT Number: NCT04213755

ROTEM in Patients With Placenta Previa

The rotational thromboelastogram (ROTEM) test can be performed on patients with placenta previa/accreta/increta/percreta who have a high likelihood of massive bleeding, and the predictors can be identified by comparing the patients who actually show massive bleeding with those who do not.

Applying these predictive factors to pregnant women undergoing cesarean section after diagnosis of placenta previa/accreta/increta/percreta, it will be advantageous for the perioperative management because it is possible to select pregnant women with a factor of massive bleeding.

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Key information

Conditions

Placenta Previa Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Placenta Accreta Placenta Diseases Placenta Increta Placenta Percreta Pregnancy Complications Urogenital Diseases

Age range

20 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Cesarean section under spinal anesthesia
  • Placenta previa
  • Placenta accreta
  • Placenta increta
  • Placenta percreta

Exclusion criteria

  • Coagulopathy
  • Medication with antiplatelets or anticoagulants

Treatment and study plan

ROTEM

Diagnostic Test

ROTEM including INTEM, EXTEM, APTEM, and FIBTEM

Primary outcomes

  1. Blood loss

    Time frame: 1 min after finishing an operation

    Volume of intraoperative blood loss

  2. Change of INTEM

    Time frame: 10 min after spinal anesthesia, 5 min after baby delivery, 1 min after finishing operation

    intrinsic pathway component

  3. Change of EXTEM

    Time frame: 10 min after spinal anesthesia, 5 min after baby delivery, 1 min after finishing operation

    extrinsic pathway component

  4. Change of APTEM

    Time frame: 10 min after spinal anesthesia, 5 min after baby delivery, 1 min after finishing operation

    fibrinolytic component

  5. Change of FIBTEM

    Time frame: 10 min after spinal anesthesia, 5 min after baby delivery, 1 min after finishing operation

    the level of fibrinogen

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Rotational Thromboelastometry During Cesarean Section as a Predictive Evaluation for Progression of Intraoperative Massive Hemorrhage in Parturients With a Potential Risk of Perioperative Hemorrhage: a Prospective Observational Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 30, 2019
Registry last updated
Nov 2, 2022

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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