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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

650 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01042483

Pregnancy Labor

UNKNOWN NA

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

NCT01093144

Pregnancy Women

UNKNOWN NA

Evaluation of Laborpro - a New Device for the Assessment of Progress of Labor

NCT00827229

Labor

COMPLETED NA

Study of Ultrasound Imaging to Predict Time and Outcome in Pregnancies With Induced Labor

NCT00465998

Pregnancy Labor, Induced

COMPLETED

Assessment of Labour Progress by Intrapartum Ultrasound

NCT04651309

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy Labor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LaborPro TrigMedical

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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