Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Determination of Labor Progression Patterns Using Non-invasive, Ultrasound Based, Multiple Parameters

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Trig Medical Inc.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Trig Medical Inc
ClinicalTrials.gov Identifier:
NCT00827125
First received: January 21, 2009
Last updated: January 4, 2010
Last verified: January 2009
  Purpose

The purpose of this study is to establish normograms of parameters measured by the LaborPro system. To test the prediction of these parameters on labor progress and mode of delivery.


Condition Intervention Phase
Pregnancy
Labor
Device: LaborPro device
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Determination of Labor Progression Patterns Using Non-invasive, Ultrasound Based, Multiple Parameters

Resource links provided by NLM:


Further study details as provided by Trig Medical Inc:

Primary Outcome Measures:
  • Assessment of the LaborPro as a prediction tool of labor progression. by introducing extended labor curves. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 650
Study Start Date: March 2009
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: LaborPro device
    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.
    Other Name: LaborPro TrigMedical
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A subject is eligible to participate in the study if he/she meets all of the following 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:

  • A subject is not eligible for participation in this study if he/she meets any of the following exclusion criteria:

    • Fetal malformations
    • Fetal distress
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827125

Contacts
Contact: Tzipi Yakoby, Director of Clinical Marketing +972-4-9597930 tzipi@TrigMed.com

Locations
United States, New York
Maimonides Medical Center Completed
Nyc, New York, United States
Israel
bnai-Zion Medical center Recruiting
Haifa, Israel
Principal Investigator: RON GONEN, Prof.         
Sponsors and Collaborators
Trig Medical Inc
  More Information

No publications provided

Responsible Party: Tzipi Yakoby, Director of Clinical Marketing, TrigMedical Inc.
ClinicalTrials.gov Identifier: NCT00827125     History of Changes
Other Study ID Numbers: CLP 032/2008CTIL
Study First Received: January 21, 2009
Last Updated: January 4, 2010
Health Authority: United States: Institutional Review Board
Israel: Ministry of Health

Keywords provided by Trig Medical Inc:
active stage
labor
progression
pregnant woman during active phases of labor

Additional relevant MeSH terms:
Disease Progression
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014