ROTEM in Patients With Placenta Previa

Completed

• Conditions: Placenta Accreta; Placenta Increta; Placenta Previa; Placenta Percreta
• Interventions: Diagnostic Test: ROTEM

• Registration Number: NCT04213755
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-24
• Study First Submitted QC: 2019-12-26
• Study First Posted: 2019-12-30
• Study Start: 2020-01-01
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with risks of intraoperative massive bleeding	ROTEM	patients with risks of intraoperative massive bleeding

Primary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of