Placenta PreviaNCT04213755
ROTEM in Patients With Placenta Previa
An observational study of Placenta Previa and Placenta Accreta, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Placenta Previa, Placenta Accreta, Placenta Increta
- What is being tested?
- ROTEM
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2020to 31 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
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
Who may be able to join
- Cesarean section under spinal anesthesia
- Placenta previa
- Placenta accreta
- Placenta increta
- Placenta percreta
Who cannot join
- Coagulopathy
- Medication with antiplatelets or anticoagulants
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
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
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.
- Conditions
- Placenta Previa, Placenta Accreta, Placenta Increta, Placenta Percreta
- Being tested
- ROTEM
- Medical subject headings
- Placenta Previa, Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROTEMDiagnostic test
ROTEM including INTEM, EXTEM, APTEM, and FIBTEM
| Study group | Role | What they receive |
|---|---|---|
| patients with risks of intraoperative massive bleeding | patients with risks of intraoperative massive bleeding Receives: Diagnostic Test: ROTEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss
Volume of intraoperative blood loss
Measured: 1 min after finishing an operation
Change of INTEM
intrinsic pathway component
Measured: 10 min after spinal anesthesia, 5 min after baby delivery, 1 min after finishing operation
Change of EXTEM
extrinsic pathway component
Measured: 10 min after spinal anesthesia, 5 min after baby delivery, 1 min after finishing operation
Change of APTEM
fibrinolytic component
Measured: 10 min after spinal anesthesia, 5 min after baby delivery, 1 min after finishing operation
Change of FIBTEM
the level of fibrinogen
Measured: 10 min after spinal anesthesia, 5 min after baby delivery, 1 min after finishing operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start1 Jan 2020
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta PreviaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Seok Na, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213755
- Sponsor's protocol ID
- ROTEM in placenta previa
- Status last verified
- Oct 2022
- First submitted
- 24 Dec 2019
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04213755
- Acronym / sponsor ID
- ROTEM in placenta previa
- Conditions
- Placenta Previa, Placenta Accreta, Placenta Increta, Placenta Percreta
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 30 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with risks of intraoperative massive bleeding | – | Diagnostic Test: ROTEMpatients with risks of intraoperative massive bleeding |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (5 listed)
- Cesarean section under spinal anesthesia
- Placenta previa
- Placenta accreta
- Placenta increta
- Placenta percreta
Key exclusion criteria (2 listed)
- Coagulopathy
- Medication with antiplatelets or anticoagulants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROTEMROTEM including INTEM, EXTEM, APTEM, and FIBTEM | Diagnostic test | patients with risks of intraoperative massive bleeding |
Primary outcome
Blood loss
Time frame: 1 min after finishing an operation
Volume of intraoperative blood loss
Change of INTEM
Time frame: 10 min after spinal anesthesia, 5 min after baby delivery, 1 min after finishing operation
intrinsic pathway component
Change of EXTEM
Time frame: 10 min after spinal anesthesia, 5 min after baby delivery, 1 min after finishing operation
extrinsic pathway component
Change of APTEM
Time frame: 10 min after spinal anesthesia, 5 min after baby delivery, 1 min after finishing operation
fibrinolytic component
Change of FIBTEM
Time frame: 10 min after spinal anesthesia, 5 min after baby delivery, 1 min after finishing operation
the level of fibrinogen
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Previa and Placenta Accreta, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood loss (time frame: 1 min after finishing an operation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022; AzTrials last refreshed its copy on 1 Nov 2026.