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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT01093144
Date of registration: 24/03/2010
Primary sponsor: Trig Medical Inc
Public title: Assessment of Pelvis Diameters as a Predictor for the Mode of Delivery ,Using Non-invasive, Ultrasound Based Measurements
Scientific title: Assessment of Pelvis Diameters as a Predictor for the Mode of Delivery ,Using Non-invasive, Ultrasound Based Measurements.
Date of first enrolment: April 2010
Target sample size: 100
Recruitment status: Not yet recruiting
URL:  http://clinicaltrials.gov/show/NCT01093144
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic  
Countries of recruitment
Israel
Contacts
Name:   Yinon Gilboa, Dr
Address: 
Telephone: +972-544776357
Email: yinon-si@inter.net.il
Affiliation: 
Name:   Yinon Gilboa, Dr
Address: 
Telephone:
Email:
Affiliation:  Tel Hashomer Medical Center
Key inclusion & exclusion criteria

Inclusion Criteria:

- A subject is eligible to participate in the study if she meets all of the following
inclusion criteria:

- Singleton pregnancy

- Pregnant adult woman in labor

- Willing to participate in the study and understands the study procedures

Exclusion Criteria:

- A subject is not eligible for participation in this study if he/she meets any of the
following exclusion criteria scheduled for c/s active infection



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Pregnancy
Women
Intervention(s)
Device: pelvic measurements using the LaborPro Device
Primary Outcome(s)
pelvis measurements influence on the Delivery mode [Time Frame: labor and delivery process]
Secondary Outcome(s)
the influence of maternal parameters on delivery mode. [Time Frame: 1 year]
Secondary ID(s)
CLP 006/2010
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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