Continuous Fetal Monitoring During Vacuum Delivery | NCT00956826

Studies
Continuous Fetal Monitoring During Vacuum Delivery

NCT00956826

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Aug 11, 2009Estimated

Enrollment

30Estimated

Phase

Early Phase 1

Conditions

Vacuum Delivery

Interventions

Agit Vacuum

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
FMV123

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Apr 2010Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Jul 19, 2009

First Submission Date that Met QC Criteria

Aug 10, 2009

First Posted Date

Aug 11, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 10, 2009

Last Update Posted Date

Aug 11, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Electrode added to device	Experimental	With an electrode and a regular vacuum device	Device: Agit Vacuum

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Agit Vacuum	Device	With an electrode and a regular vacuum device	Electrode added to device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of fetal heart rate monitoring in both arms		12 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All fetuses at vacuum delivery

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

1 Day

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
David Mankuta, MD	Contact	02 6776111
Gal Nasi, BsC	Contact	02 6776111

Overall Officials

Name	Affiliation	Role
David Mankuta, MD	Hadassah	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Ein Kerem		Jerusalem			Israel