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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04213755
Enrollment
100
Registered
2019-12-30
Start date
2020-01-01
Completion date
2022-08-31
Last updated
2022-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Placenta Previa, Placenta Accreta, Placenta Increta, Placenta Percreta

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.

Interventions

DIAGNOSTIC_TESTROTEM

ROTEM including INTEM, EXTEM, APTEM, and FIBTEM

Sponsors

Seoul National University Bundang Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Coagulopathy * Medication with antiplatelets or anticoagulants

Design outcomes

Primary

MeasureTime frameDescription
Blood loss1 min after finishing an operationVolume of intraoperative blood loss
Change of INTEM10 min after spinal anesthesia, 5 min after baby delivery, 1 min after finishing operationintrinsic pathway component
Change of EXTEM10 min after spinal anesthesia, 5 min after baby delivery, 1 min after finishing operationextrinsic pathway component
Change of APTEM10 min after spinal anesthesia, 5 min after baby delivery, 1 min after finishing operationfibrinolytic component
Change of FIBTEM10 min after spinal anesthesia, 5 min after baby delivery, 1 min after finishing operationthe level of fibrinogen

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026