NCT00827229

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2007

Status
completed

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, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 22, 2009

Completed
Last Updated

January 22, 2009

Status Verified

January 1, 2009

Enrollment Period

11 months

First QC Date

January 21, 2009

Last Update Submit

January 21, 2009

Conditions

Labor

Keywords

Active laborTerm pregnancyVertex presentationSingle fetus

Study Arms (1)

LaborPro, active Labor, Vaginal Examination

OTHER
Device: Labor Monitor

Interventions

Labor MonitorDEVICE
LaborPro, active Labor, Vaginal Examination

Eligibility Criteria

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

You may qualify if:

  • Active phase of labor
  • Singleton pregnancy (as diagnosed by ultrasound)
  • Cephalic presentation

You may not qualify if:

  • Known or suspected disease of mother or fetus from among the following:
  • Positive HIV testing
  • Positive Hepatitis B Surface Antigen testing
  • Active Genital Herpes Simplex
  • Coagulation disorders
  • Fetal distress
  • Inability to provide informed consent or comply with study protocol
  • Abnormal placentation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 21, 2009

First Posted

January 22, 2009

Study Start

January 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

January 22, 2009

Record last verified: 2009-01