Determination of Labor Progression Patterns Using Non-invasive, Ultrasound Based, Multiple Parameters
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 4/2/2016 |
| Start Date: | March 2009 |
| End Date: | February 2010 |
| Contact: | Tzipi Yakoby, Director of Clinical Marketing |
| Email: | tzipi@TrigMed.com |
| Phone: | +972-4-9597930 |
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.
system. To test the prediction of these parameters on labor progress and mode of delivery.
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.
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.
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
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