Status:
UNKNOWN
Determination of Labor Progression Patterns Using Non-invasive, Ultrasound Based, Multiple Parameters
Lead Sponsor:
Trig Medical Inc
Conditions:
Pregnancy
Labor
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to establish normograms of parameters measured by the LaborPro system. To test the prediction of these parameters on labor progress and mode of delivery.
Detailed Description
Intrapartum assessment of the fetal head position and station, and cervical dilatation are essential for the management of labor. Precise knowledge of these parameters assists in the correct identific...
Eligibility Criteria
Inclusion
- A subject is eligible to participate in the study if he/she meets all of the following inclusion criteria:
- Singleton pregnancy
- Pregnant adult woman in labor
- Gestational age 37-42 wks
- Vertex presentation
- Willing to participate in the study and understands the study
Exclusion
- A subject is not eligible for participation in this study if he/she meets any of the following exclusion criteria:
- Fetal malformations
- Fetal distress
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2010
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT00827125
Start Date
March 1 2009
End Date
February 1 2010
Last Update
January 5 2010
Active Locations (2)
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1
Maimonides Medical Center
New York, New York, United States
2
bnai-Zion Medical center
Haifa, Israel