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
1 other identifier
observational
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 24, 2019
CompletedFirst Posted
Study publicly available on registry
December 30, 2019
CompletedStudy Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2022
CompletedNovember 2, 2022
October 1, 2022
2.7 years
December 24, 2019
October 31, 2022
Conditions
Outcome Measures
Primary Outcomes (5)
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
Study Arms (1)
patients with risks of intraoperative massive bleeding
patients with risks of intraoperative massive bleeding
Interventions
ROTEM including INTEM, EXTEM, APTEM, and FIBTEM
Eligibility Criteria
Pregnant women over 20 years old who are scheduled for cesarean section under spinal anesthesia after diagnosis of placenta previa/increta/percreta/accreta
You may qualify if:
- Cesarean section under spinal anesthesia
- Placenta previa
- Placenta accreta
- Placenta increta
- Placenta percreta
You may not qualify if:
- Coagulopathy
- Medication with antiplatelets or anticoagulants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
December 24, 2019
First Posted
December 30, 2019
Study Start
January 1, 2020
Primary Completion
August 31, 2022
Study Completion
August 31, 2022
Last Updated
November 2, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share