- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00956826
Continuous Fetal Monitoring During Vacuum Delivery
August 10, 2009 updated by: Hadassah Medical Organization
Continuous Fetal Monitoring During Vacuum Delivery an Addition of a New Device
The investigators have added an additional electrode to the vacuum device for birth in which they can monitor the fetus during delivery.
Study Overview
Detailed Description
The investigators have added an additional electrode to the vacuum device for birth in which they can monitor the fetus during delivery.
The electrode is a standard one inserted in the vacuum device.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: David Mankuta, MD
- Phone Number: 02 6776111
Study Contact Backup
- Name: Gal Nasi, BsC
- Phone Number: 02 6776111
Study Locations
-
-
-
Jerusalem, Israel
- Hadassah Ein Kerem
-
-
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
1 day to 1 day (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All fetuses at vacuum delivery
Exclusion Criteria:
- None
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
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Electrode added to device
With an electrode and a regular vacuum device
|
With an electrode and a regular vacuum device
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of fetal heart rate monitoring in both arms
Time Frame: 12 month
|
12 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: David Mankuta, MD, Hadassah
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
September 1, 2009
Primary Completion (Anticipated)
April 1, 2010
Study Completion (Anticipated)
December 1, 2010
Study Registration Dates
First Submitted
July 19, 2009
First Submitted That Met QC Criteria
August 10, 2009
First Posted (Estimate)
August 11, 2009
Study Record Updates
Last Update Posted (Estimate)
August 11, 2009
Last Update Submitted That Met QC Criteria
August 10, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- fetal monitoring vaccum
- FMV123
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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