Continuous Fetal Monitoring During Vacuum Delivery

Vacuum Delivery Clinical Trial

Official title:

Continuous Fetal Monitoring During Vacuum Delivery an Addition of a New Device

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00956826
• Other study ID #: fetal monitoring vaccum
• Secondary ID: FMV123
• Status: Not yet recruiting
• Phase: Phase 0
• First received: July 19, 2009
• Last updated: August 10, 2009
• Start date: September 2009
• Est. completion date: December 2010

Study information

• Verified date: August 2009
• Source: Hadassah Medical Organization
• Contact: David Mankuta, MD
• Phone: 02 6776111
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Day

Eligibility

Inclusion Criteria:

• All fetuses at vacuum delivery

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Vacuum Delivery

Intervention

Device:
• Agit Vacuum
With an electrode and a regular vacuum device

Locations

Country	Name	City	State
Israel	Hadassah Ein Kerem	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of fetal heart rate monitoring in both arms		12 month	No