Continuous Fetal Monitoring During Vacuum Delivery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00956826
First received: July 19, 2009
Last updated: August 10, 2009
Last verified: August 2009
  Purpose

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


Condition Intervention Phase
Vacuum Delivery
Device: Agit Vacuum
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Continuous Fetal Monitoring During Vacuum Delivery an Addition of a New Device

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Quality of fetal heart rate monitoring in both arms [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 1 Day
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All fetuses at vacuum delivery

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: David Mankuta, Hadassah University Hospital
ClinicalTrials.gov Identifier: NCT00956826     History of Changes
Other Study ID Numbers: fetal monitoring vaccum, FMV123
Study First Received: July 19, 2009
Last Updated: August 10, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
electrode vacuum delivery

ClinicalTrials.gov processed this record on October 23, 2014