Study to Determine if Monitoring of Labor Shortens the Ti... | NCT01005667

Studies
Study to Determine if Monitoring of Labor Shortens the Time to Delivery

NCT01005667

Sponsor

Barnev, Inc.

Status

Withdrawn

Last Update Posted

Jun 23, 2011Estimated

Enrollment

600Estimated

Phase

Not Applicable

Conditions

Pregnancy

Interventions

BirthTrack

Countries

Canada

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

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of funding for the company has resulted in termination of the study.

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 30, 2009

First Submission Date that Met QC Criteria

Oct 30, 2009

First Posted Date

Nov 2, 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

Jun 22, 2011

Last Update Posted Date

Jun 23, 2011Estimated

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 purpose of this study is to test the hypothesis that using the BirthTrack for management of labor shortens the time to delivery and thus improves both maternal and perinatal outcomes.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BirthTrack Monitor	Experimental		Device: BirthTrack
Control - no BirthTrack Monitor	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BirthTrack	Device	Measurement of cervical dilation and head station	BirthTrack Monitor

Measure	Description	Time Frame
Shortened time to vaginal delivery		Length of labor until delivery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patient must be ≥ 18 years old
Nulliparous
Singleton fetus in vertex presentation
Gestational age 36-0/7 or more
Reassuring fetal heart tracing

Exclusion Criteria:

Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study
Low lying placenta (edge 3cm or less from cervix)
Known or suspected fetal or maternal infection
Maternal thrombocytopenia (platelet count <100,000)
Maternal bleeding disorder
Women with previous uterine surgery
Known major fetal malformation
Suspected fetal growth restriction (EFW<10th percentile)
Subjects with significant psychiatric history
Major maternal morbidity (e.g. major cardiac disease)
Subjects with indication for immediate delivery
Limit on cervical dilation (e.g., up to 7 cm.)
Prolonged rupture of membranes (i.e., > 24 hours)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Barak M Rosenn, MD	St. Luke's-Roosevelt Hospital Center	Principal Investigator
Dan Farine, MD	MOUNT SINAI HOSPITAL	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mount Sinai Hospital		Toronto	Ontario	M5G 1X5	Canada