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NCT01093144 Clinical Trial

Assessment of Pelvis Diameters as a Predictor for the Mode of Delivery ,Using Non-invasive, Ultrasound Based Measurements

Pregnancy Clinical Trial

Official title:
Assessment of Pelvis Diameters as a Predictor for the Mode of Delivery ,Using Non-invasive, Ultrasound Based Measurements.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01093144
Other study ID # CLP 006/2010
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 24, 2010
Last updated March 24, 2010
Start date April 2010
Est. completion date April 2010

Study information
Verified date March 2010
Source Trig Medical Inc
Contact Yinon Gilboa, Dr
Phone +972-544776357
Email yinon-si@inter.net.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

Assessing the relation between the Pelvis diameters measured by the LaborPro, and the mode of delivery(normal vaginal delivery/instrumental delivery/Caesarean section.

Description:

Assessing the relation between the Pelvis diameters measured by the LaborPro, and the mode of delivery(normal vaginal delivery/instrumental delivery/Caesarean section.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date April 2010
Est. primary completion date April 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• pelvic measurements using the LaborPro Device
pelvic measurements using the LaborPro Device,ultrasound non invasive measurements

Locations
Country Name City State
Israel Shiba Medical Center Tel Aviv

Sponsors (1)
Lead Sponsor Collaborator
Trig Medical Inc

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary pelvis measurements influence on the Delivery mode pregnant woman's during a routine visit in the ultrasound unit will be requested to sign a concent and will undergo pelvic measurement using the LaborPro system.
statistic analysis will ensue in order to ascertain the relationship between pelvic measurement and the mode of delivery.		 labor and delivery process No
Secondary the influence of maternal parameters on delivery mode. Assessing the influence of relevant obstetric and maternal parameters on delivery mode in relation to the study measured parameters 1 year No
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