Status:
COMPLETED
Evaluation of Laborpro - a New Device for the Assessment of Progress of Labor
Lead Sponsor:
Trig Medical Inc
Conditions:
Labor
Eligibility:
FEMALE
18+ years
Phase:
NA
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/d...
Detailed Description
Objective The purpose of the study was to evaluate the accuracy of LaborPro fetal head station, fetal head position, and cervical dilatation measurements as compared to manual/digital examinations and...
Eligibility Criteria
Inclusion
- Active phase of labor
- Singleton pregnancy (as diagnosed by ultrasound)
- Cephalic presentation
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00827229
Start Date
January 1 2007
End Date
December 1 2007
Last Update
January 22 2009
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.