MedTrace Logo

Evaluation of Laborpro - a New Device for the Assessment of Progress of Labor

NCT00827229 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2009-01-22

No results posted yet for this study

Summary

A clinical study was conducted to demonstrate the accuracy of the LaborPro System in measuring fetal head station (from the pelvic inlet), cervical dilatation, and fetal head position against manual/digital examination. The LaborPro obtained device values was compared to measurements gathered within 15 minutes by manual/digital examination performed by two independent physicians. The study was a non significant risk (NSR) device study.

Conditions

  • Labor

Interventions

DEVICE

Labor Monitor

Sponsors & Collaborators

  • Trig Medical Inc

    lead INDUSTRY

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2007-12-31
Completion
2007-12-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00827229 on ClinicalTrials.gov