Cesarean Delivery With Placental PreviaNCT00985764
Venous Air Embolism in Cesarean Delivery, Especially Placental Previa
An observational study of Cesarean Delivery With Placental Previa, run by Yonsei University at 1 site in South Korea.
Trial summary
Effects of placenta previa on incidence and severity of venous air embolism in patients during cesarean delivery Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Cesarean Delivery With Placental Previa
- What is being tested?
- cesarean delivery
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2007to Sep 2009
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: cesarean delivery with placental previa
Who may be able to join
- Healthy Volunteer with cesarean delivery
Who cannot join
- the one who rejects to participate
Trial locations and contacts
1 site in 1 country.
About this study
Effects of placenta previa on incidence and severity of venous air embolism in patients during cesarean delivery
- Conditions
- Cesarean Delivery With Placental Previa
- Being tested
- cesarean delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cesarean deliveryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| placental previa | Not described Receives: Procedure: cesarean delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
read sonography records during the surgery
Three sono views will be recorded rapidly for later interpretation of the stage of air embolism. The midesophageal (ME) 4-chamber view will be continuously monitored during surgery and videotaped. When a bubble is detected in the right atrium (RA), the probe will be turned to the right side and the angle was adjusted to the ME bicaval view to confirm its entrance from the inferior vena cava. Then, the angle will be rapidly re-adjusted to view the ME right ventricle (RV) inflow-outflow view to confirm the extent of air embolism through the right ventricular outflow tract (RVOT).
Measured: After 1 or 2 weeks of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2009 (estimated)
- Study startMay 2007
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Delivery With Placental PreviaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985764
- Sponsor's protocol ID
- 4-2007-0006
- Status last verified
- Oct 2010
- First submitted
- 25 Sep 2009
- Last updated
- 4 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Air Embolism in Cesarean Delivery, Especially Placental Previa
- ClinicalTrials.gov ID
- NCT00985764
- Acronym / sponsor ID
- 4-2007-0006
- Conditions
- Cesarean Delivery With Placental Previa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 28 Sep 2009 (estimated)
- 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.
Effects of placenta previa on incidence and severity of venous air embolism in patients during cesarean delivery
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| placental previa | – | Procedure: cesarean delivery |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- cesarean delivery with placental previa
Key inclusion criteria (1 listed)
- Healthy Volunteer with cesarean delivery
Key exclusion criteria (1 listed)
- the one who rejects to participate
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 |
|---|---|---|
| cesarean delivery | Procedure or surgery | placental previa |
Primary outcome
read sonography records during the surgery
Time frame: After 1 or 2 weeks of surgery
Three sono views will be recorded rapidly for later interpretation of the stage of air embolism. The midesophageal (ME) 4-chamber view will be continuously monitored during surgery and videotaped. When a bubble is detected in the right atrium (RA), the probe will be turned to the right side and the angle was adjusted to the ME bicaval view to confirm its entrance from the inferior vena cava. Then, the angle will be rapidly re-adjusted to view the ME right ventricle (RV) inflow-outflow view to confirm the extent of air embolism through the right ventricular outflow tract (RVOT).
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 4 Nov 2010.
Related trials for Cesarean Delivery With Placental Previa
Not yet recruiting
ERAS Protocol for Cesarean Delivery in Women With Placenta Previa
Placenta Previa
Not yet recruitingObservational study
Hematological and Coagulation Markers in Predicting Placenta Accreta Spectrum in Placenta Previa
Placenta Accreta Spectrum, Placenta Previa
Recruiting
Planned Delivery at 37 Versus 36 Weeks in Pregnancies With Placenta Previaand Accreta
Placenta Previa, Placenta Accreta Spectrum
RecruitingPhase 3
TRAnexamic Acid for Preventing Blood Loss Following a Cesarean Delivery in Women With Placenta pREVIA
Postpartum Hemorrhage
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 Cesarean Delivery With Placental Previa, run by Yonsei University 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 1 inclusion and 1 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 4 Nov 2010. 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?
read sonography records during the surgery (time frame: After 1 or 2 weeks of surgery). 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 4 Nov 2010.