ROTEM in Patients With Placenta Previa

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

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.

Study Overview

• Status: Completed
• Conditions: Placenta Accreta; Placenta Previa; Placenta Percreta; Placenta Increta
• Intervention / Treatment: Diagnostic test: ROTEM

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi
    • Seongnam, Gyeonggi, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women over 20 years old who are scheduled for cesarean section under spinal anesthesia after diagnosis of placenta previa/increta/percreta/accreta

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Coagulopathy
• Medication with antiplatelets or anticoagulants

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with risks of intraoperative massive bleeding	Diagnostic test: ROTEM; ROTEM including INTEM, EXTEM, APTEM, and FIBTEM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss	Volume of intraoperative blood loss	1 min after finishing an operation
Change of INTEM	intrinsic pathway component	10 min after spinal anesthesia, 5 min after baby delivery, 1 min after finishing operation
Change of EXTEM	extrinsic pathway component	10 min after spinal anesthesia, 5 min after baby delivery, 1 min after finishing operation
Change of APTEM	fibrinolytic component	10 min after spinal anesthesia, 5 min after baby delivery, 1 min after finishing operation
Change of FIBTEM	the level of fibrinogen	10 min after spinal anesthesia, 5 min after baby delivery, 1 min after finishing operation

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: December 24, 2019
• First Submitted That Met QC Criteria: December 26, 2019
• First Posted (Actual): December 30, 2019

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Placenta Accreta; Placenta Previa
• Other Study ID Numbers: ROTEM in placenta previa

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No