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Determination of Labor Progression Patterns Using Non-invasive, Ultrasound Based+Continuous Vacuum Mode

Primary Purpose

Pregnancy, Labor

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
LaborPro device
Sponsored by
Trig Medical Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pregnancy focused on measuring active stage, labor, progression, pregnant women during active phases of labor

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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 Criteria:

  • Fetal malformations
  • Fetal distress

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Assessment of the LaborPro as a prediction tool of labor progression. by introducing extended labor curves.

    Secondary Outcome Measures

    Assessing the influence of obstetric and maternal parameters on the labor progression,relation between the pelvis diameters and Pubic Arch Angle measured by the LaborPro, and labor progression and mode of delivery,Maternal Satisfaction.
    Measurements of fetal head station and position during performing vacuum extraction delivery by attaching the positon sensor (1.3 mm) to the vacuum cup.

    Full Information

    First Posted
    January 3, 2010
    Last Updated
    January 4, 2010
    Sponsor
    Trig Medical Inc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01042483
    Brief Title
    Determination of Labor Progression Patterns Using Non-invasive, Ultrasound Based+Continuous Vacuum Mode
    Official Title
    Determination of Labor Progression Patterns Using Non-invasive, Ultrasound Based, Multiple Parameters+Continuous Vacuum Mode
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2010
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2010 (undefined)
    Primary Completion Date
    February 2011 (Anticipated)
    Study Completion Date
    February 2011 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Trig Medical Inc

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to establish normograms of parameters measured by the LaborPro system, and 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 identification of normal versus abnormal labor progression patterns, and in case of the latter, indicates when medical or operative intervention may be required. Digital examination remains the "gold standard" for evaluation of head station and position and cervical dilatation in pregnancy; however, it has inherent variability. evaluations of the reliability of cervical dilatation assessment were performed initially in models, and more recently in patients during labor. Accuracy in models ranges from 51% to 59% and falls under 50% when evaluated in patients. However, labor management has changed substantially since then. Induction of labor, oxytocin use, epidural analgesia, and fetal heart rate monitoring are very common in contemporary practice whereas breech vaginal delivery and mid forceps are rarely performed. The mean body mass of women is significantly higher than it was 50 years ago, which may contribute to the increased fetal size, and the second stage is prolonged, as it increasingly occurs with use of epidural analgesia. Some studies suggested that the Friedman curve was no longer appropriate for induced or actively managed labor. In addition, once full dilatation is reached, although descent continues, monitoring of cervical dilation is no longer useful in the second stage. Descent in the second stage of labor is accompanied by rotation of the presenting part as it negotiates the pelvis. Friedman and Sachtleben showed that arrest of descent was frequently associated with fetal malpositions and suggested that abnormalities of rotation were important prognostic factors in the second stage. The rates of caesarean section have been a major public health concern. Non progressive labor is the leading cause of primary C-sections in the US. It is well known that non-progressive labor is over diagnosed, and determination of the patterns of normal and abnormal labor is fundamental to the formulation of strategies to reduce caesarean section rates. In the US, the total cesarean delivery rate for 2005 rose to the highest level ever reported - 30.3%.After declining between 1989 and 1996, the cesarean rate has increased by 46 percent from the 1996 low of 20.7. The American College of Obstetricians and Gynecologists Task Force on Caesarian Delivery Rates (2000) recommended a C-section rate of 15.5% for nulliparous women for the US for the year 2010. The LaborPro provides a tool for frequent non-invasive evaluation of head station and position, head descend, head descend during contraction, head position, and head rotation, without increasing the risk of maternal/fetal infection related to the number of vaginal examinations. In addition, a ruler-like determination of cervical dilatation is available during TVDE, as well as measurements of Pelvis diameters.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pregnancy, Labor
    Keywords
    active stage, labor, progression, pregnant women during active phases of labor

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    450 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    LaborPro device
    Other Intervention Name(s)
    LaborPro TrigMedical
    Intervention Description
    monitoring labor progression by using a new device The LaborPro system (Trig Medical Inc) allows determination of fetal head station and position using ultrasound and position tracking system.
    Primary Outcome Measure Information:
    Title
    Assessment of the LaborPro as a prediction tool of labor progression. by introducing extended labor curves.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Assessing the influence of obstetric and maternal parameters on the labor progression,relation between the pelvis diameters and Pubic Arch Angle measured by the LaborPro, and labor progression and mode of delivery,Maternal Satisfaction.
    Time Frame
    1 year
    Title
    Measurements of fetal head station and position during performing vacuum extraction delivery by attaching the positon sensor (1.3 mm) to the vacuum cup.
    Time Frame
    1 year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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 Criteria: Fetal malformations Fetal distress
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tzipi Yakoby, Director of Clinical Marketing
    Phone
    +972-4-9597930
    Ext
    31
    Email
    tzipi@TrigMed.com

    12. IPD Sharing Statement

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