- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00985764
Venous Air Embolism in Cesarean Delivery, Especially Placental Previa
November 3, 2010 updated by: Yonsei University
Effects of placenta previa on incidence and severity of venous air embolism in patients during cesarean delivery
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Seoul, Korea, Republic of
- Severance Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
cesarean delivery with placental previa
Description
Inclusion Criteria:
- Healthy Volunteer with cesarean delivery
Exclusion Criteria:
- the one who rejects to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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placental previa
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
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After 1 or 2 weeks of surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
September 25, 2009
First Submitted That Met QC Criteria
September 25, 2009
First Posted (Estimate)
September 28, 2009
Study Record Updates
Last Update Posted (Estimate)
November 4, 2010
Last Update Submitted That Met QC Criteria
November 3, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- 4-2007-0006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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