ROTEM in Patients With Placenta Previa

NCT ID: NCT04213755

Last Updated: 2022-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-08-31

Brief Summary

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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

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Conditions

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Placenta Previa Placenta Accreta Placenta Increta Placenta Percreta

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with risks of intraoperative massive bleeding

patients with risks of intraoperative massive bleeding

ROTEM

Intervention Type DIAGNOSTIC_TEST

ROTEM including INTEM, EXTEM, APTEM, and FIBTEM

Interventions

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ROTEM

ROTEM including INTEM, EXTEM, APTEM, and FIBTEM

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Coagulopathy
* Medication with antiplatelets or anticoagulants
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyo-Seok Na

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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ROTEM in placenta previa

Identifier Type: -

Identifier Source: org_study_id

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