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Continuous Fetal Monitoring During Vacuum Delivery

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ClinicalTrials.gov Identifier: NCT00956826
Recruitment Status : Unknown
Verified August 2009 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : August 11, 2009
Last Update Posted : August 11, 2009
Sponsor:
Information provided by:
Hadassah Medical Organization

Brief Summary:
The investigators have added an additional electrode to the vacuum device for birth in which they can monitor the fetus during delivery.

Condition or disease Intervention/treatment Phase
Vacuum Delivery Device: Agit Vacuum Early Phase 1

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Continuous Fetal Monitoring During Vacuum Delivery an Addition of a New Device
Study Start Date : September 2009
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Electrode added to device
With an electrode and a regular vacuum device
Device: Agit Vacuum
With an electrode and a regular vacuum device
Other Name: Agit Vaccum



Primary Outcome Measures :
  1. Quality of fetal heart rate monitoring in both arms [ Time Frame: 12 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All fetuses at vacuum delivery

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00956826


Contacts
Contact: David Mankuta, MD 02 6776111
Contact: Gal Nasi, BsC 02 6776111

Locations
Israel
Hadassah Ein Kerem Not yet recruiting
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Study Chair: David Mankuta, MD Hadassah

Responsible Party: David Mankuta, Hadassah University Hospital
ClinicalTrials.gov Identifier: NCT00956826     History of Changes
Other Study ID Numbers: fetal monitoring vaccum
FMV123
First Posted: August 11, 2009    Key Record Dates
Last Update Posted: August 11, 2009
Last Verified: August 2009

Keywords provided by Hadassah Medical Organization:
electrode vacuum delivery