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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04213755
Other study ID # ROTEM in placenta previa
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date August 31, 2022

Study information

Verified date October 2022
Source Seoul National University Bundang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date August 31, 2022
Est. primary completion date August 31, 2022
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria: - Cesarean section under spinal anesthesia - Placenta previa - Placenta accreta - Placenta increta - Placenta percreta Exclusion Criteria: - Coagulopathy - Medication with antiplatelets or anticoagulants

Study Design


Intervention

Diagnostic Test:
ROTEM
ROTEM including INTEM, EXTEM, APTEM, and FIBTEM

Locations

Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam Gyeonggi

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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