Determination of Labor Progression Patterns Using Non-invasive, Ultrasound Based, Multiple Parameters
Primary Purpose
Pregnancy, Labor
Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LaborPro device
Sponsored by
About this trial
This is an interventional diagnostic trial for Pregnancy focused on measuring active stage, labor, progression, pregnant woman during active phases of labor
Eligibility 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
Sites / Locations
- Maimonides Medical Center
- bnai-Zion Medical centerRecruiting
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00827125
Brief Title
Determination of Labor Progression Patterns Using Non-invasive, Ultrasound Based, Multiple Parameters
Official Title
Determination of Labor Progression Patterns Using Non-invasive, Ultrasound Based, Multiple Parameters
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
February 2010 (Anticipated)
Study Completion Date
February 2010 (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. 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 woman during active phases of labor
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
650 (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
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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tzipi Yakoby, Director of Clinical Marketing
Phone
+972-4-9597930
Email
tzipi@TrigMed.com
Facility Information:
Facility Name
Maimonides Medical Center
City
Nyc
State/Province
New York
Country
United States
Individual Site Status
Completed
Facility Name
bnai-Zion Medical center
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RON GONEN, Prof.
12. IPD Sharing Statement
Citations:
PubMed Identifier
32120420
Citation
Haberman S, Atallah F, Nizard J, Buhule O, Albert P, Gonen R, Ville Y, Paltieli Y. A Novel Partogram for Stages 1 and 2 of Labor Based on Fetal Head Station Measured by Ultrasound: A Prospective Multicenter Cohort Study. Am J Perinatol. 2021 Aug;38(S 01):e14-e20. doi: 10.1055/s-0040-1702989. Epub 2020 Mar 2.
Results Reference
derived
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Determination of Labor Progression Patterns Using Non-invasive, Ultrasound Based, Multiple Parameters
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