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

First Received on July 19, 2009. Last Updated on August 10, 2009 History of Changes

Sponsor:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00956826

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:

Drug Information available for: Dihydroergotamine Dihydroergotamine mesylate

U.S. FDA Resources

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

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

Additional relevant MeSH terms:

Dihydroergotamine
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Analgesics, Non-Narcotic

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012