NCT01042483

Brief Summary

The purpose of this study is to establish normograms of parameters measured by the LaborPro system, and to test the prediction of these parameters on labor progress and mode of delivery.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started Jan 2010

Shorter than P25 for not_applicable pregnancy

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

January 5, 2010

Status Verified

January 1, 2010

Enrollment Period

1.1 years

First QC Date

January 3, 2010

Last Update Submit

January 4, 2010

Conditions

PregnancyLabor

Keywords

active stagelaborprogressionpregnant women during active phases of labor

Outcome Measures

Primary Outcomes (1)

  • Assessment of the LaborPro as a prediction tool of labor progression. by introducing extended labor curves.

    1 year

Secondary Outcomes (2)

  • Assessing the influence of obstetric and maternal parameters on the labor progression,relation between the pelvis diameters and Pubic Arch Angle measured by the LaborPro, and labor progression and mode of delivery,Maternal Satisfaction.

    1 year

  • Measurements of fetal head station and position during performing vacuum extraction delivery by attaching the positon sensor (1.3 mm) to the vacuum cup.

    1 year

Interventions

LaborPro deviceDEVICE

monitoring labor progression by using a new device The LaborPro system (Trig Medical Inc) allows determination of fetal head station and position using ultrasound and position tracking system.

Also known as: LaborPro TrigMedical

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Singleton pregnancy
  • Pregnant adult woman in labor
  • Gestational age 37-42 wks
  • Vertex presentation
  • Willing to participate in the study and understands the study

You may not qualify if:

  • Fetal malformations
  • Fetal distress

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Disease Progression

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Tzipi Yakoby, Director of Clinical Marketing

CONTACT

+972-4-9597930tzipi@TrigMed.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 3, 2010

First Posted

January 5, 2010

Study Start

January 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

January 5, 2010

Record last verified: 2010-01