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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2010 by Trig Medical Inc.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01093144
First Posted: March 25, 2010
Last Update Posted: March 25, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Trig Medical Inc
  Purpose
Assessing the relation between the Pelvis diameters measured by the LaborPro, and the mode of delivery(normal vaginal delivery/instrumental delivery/Caesarean section.

Condition Intervention
Pregnancy Women Device: pelvic measurements using the LaborPro Device

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Pelvis Diameters as a Predictor for the Mode of Delivery ,Using Non-invasive, Ultrasound Based Measurements.

Further study details as provided by Trig Medical Inc:

Primary Outcome Measures:
  • pelvis measurements influence on the Delivery mode [ Time Frame: labor and delivery process ]

    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.



Secondary Outcome Measures:
  • the influence of maternal parameters on delivery mode. [ Time Frame: 1 year ]
    Assessing the influence of relevant obstetric and maternal parameters on delivery mode in relation to the study measured parameters


Estimated Enrollment: 100
Study Start Date: April 2010
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: pelvic measurements using the LaborPro Device
    pelvic measurements using the LaborPro Device,ultrasound non invasive measurements
Detailed Description:
Assessing the relation between the Pelvis diameters measured by the LaborPro, and the mode of delivery(normal vaginal delivery/instrumental delivery/Caesarean section.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01093144


Contacts
Contact: Yinon Gilboa, Dr +972-544776357 yinon-si@inter.net.il
Contact: Tzipi Yakoby +972507992200 tzipi@trigmed.com

Locations
Israel
Shiba Medical Center Not yet recruiting
Tel Aviv, Israel
Sponsors and Collaborators
Trig Medical Inc
Investigators
Principal Investigator: Yinon Gilboa, Dr Tel Hashomer Medical Center
  More Information

Responsible Party: Tzipi Yakoby, Trig Medical Inc
ClinicalTrials.gov Identifier: NCT01093144     History of Changes
Other Study ID Numbers: CLP 006/2010
First Submitted: March 24, 2010
First Posted: March 25, 2010
Last Update Posted: March 25, 2010
Last Verified: March 2010

Keywords provided by Trig Medical Inc:
Delivery mode
pelvic measurement