NCT01005667

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 2, 2009

Completed
Last Updated

June 23, 2011

Status Verified

October 1, 2009

First QC Date

October 30, 2009

Last Update Submit

June 22, 2011

Conditions

Pregnancy

Keywords

Nulliparous women in spontaneous labor

Outcome Measures

Primary Outcomes (1)

  • Shortened time to vaginal delivery

    Length of labor until delivery

Study Arms (2)

BirthTrack Monitor

EXPERIMENTAL
Device: BirthTrack

Control - no BirthTrack Monitor

NO INTERVENTION

Interventions

BirthTrackDEVICE

Measurement of cervical dilation and head station

Also known as: Computerized Labor Monitoring System
BirthTrack Monitor

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Study Officials

  • Barak M Rosenn, MD

    St. Luke's-Roosevelt Hospital Center

    PRINCIPAL INVESTIGATOR

  • Dan Farine, MD

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 30, 2009

First Posted

November 2, 2009

Last Updated

June 23, 2011

Record last verified: 2009-10

Locations

CA(1)