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

March 24, 2010 updated by: Trig Medical Inc

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel
        • Shiba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
labor and delivery process

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trig Medical Inc

Investigators

  • Principal Investigator: Yinon Gilboa, Dr, Tel Hashomer Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

April 1, 2010

Study Completion (Anticipated)

April 1, 2010

Study Registration Dates

First Submitted

March 24, 2010

First Submitted That Met QC Criteria

March 24, 2010

First Posted (Estimate)

March 25, 2010

Study Record Updates

Last Update Posted (Estimate)

March 25, 2010

Last Update Submitted That Met QC Criteria

March 24, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CLP 006/2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pregnancy

Clinical Trials on pelvic measurements using the LaborPro Device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe