ROTEM in Patients With Placenta Previa

Placenta Accreta Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04213755
• Other study ID #: ROTEM in placenta previa
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Placenta Accreta
• Placenta Increta
• Placenta Percreta
• Placenta Previa

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