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CompletedNCT04213755Updated Nov 2, 2022

ROTEM in Patients With Placenta Previa

An observational study in Placenta Previa, Placenta Accreta and Placenta Increta, sponsored by Seoul National University Bundang Hospital. Completed at 1 site in Korea, Republic of. Open to female participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2022-11-02.

Sponsored by Seoul National University Bundang Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
20 Years to 50 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Placenta Previa
  • Placenta Accreta
  • Placenta Increta
  • Placenta Percreta
03

In context

Placenta Previa

80 studies on the registry are indexed under Placenta Previa; 17 are open to participants now.

This study's enrollment of 100 is close to the median of 100 across 32 observational studies indexed under Placenta Previa.

Browse Placenta Previa studies →

Lead sponsor

Seoul National University Bundang Hospital is the lead sponsor of 376 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pregnant women over 20 years old who are scheduled for cesarean section under spinal anesthesia after diagnosis of placenta previa/increta/percreta/accreta

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Coagulopathy
  • Medication with antiplatelets or anticoagulants
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • patients with risks of intraoperative massive bleeding

    patients with risks of intraoperative massive bleeding

    Diagnostic Test: ROTEM

Interventions

  • Diagnostic testROTEM

    ROTEM including INTEM, EXTEM, APTEM, and FIBTEM

06

What researchers measure

Primary outcomes

  1. Blood loss

    Volume of intraoperative blood loss

    Time frame: 1 min after finishing an operation

  2. Change of INTEM

    intrinsic pathway component

    Time frame: 10 min after spinal anesthesia, 5 min after baby delivery, 1 min after finishing operation

  3. Change of EXTEM

    extrinsic pathway component

    Time frame: 10 min after spinal anesthesia, 5 min after baby delivery, 1 min after finishing operation

  4. Change of APTEM

    fibrinolytic component

    Time frame: 10 min after spinal anesthesia, 5 min after baby delivery, 1 min after finishing operation

  5. Change of FIBTEM

    the level of fibrinogen

    Time frame: 10 min after spinal anesthesia, 5 min after baby delivery, 1 min after finishing operation

07

Study locations

1 site
  • Seoul National University Bundang Hospital
    Seongnam, Gyeonggi 13620, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04213755
Responsible party
Hyo-Seok Na (Principal investigator, Seoul National University Bundang Hospital) — Principal investigator
First posted
Dec 30, 2019
Start date
Jan 1, 2020
Primary completion
Aug 31, 2022
Completion
Aug 31, 2022
Last update
Nov 2, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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