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PregnancyPhase 2NCT00827125

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

A Phase 2 study testing LaborPro device in people with Pregnancy and Labor, run by Trig Medical Inc at 2 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy, Labor
What is being tested?
LaborPro device
Type of treatment
Medical device
How many people
650 participants
Where
2 sitesin 2 countries
Study dates
Mar 2009to Feb 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 2 countries.

Tzipi Yakoby, Director of Clinical Marketing contact

+972-4-9597930

tzipi@TrigMed.com

2 sites in 2 countries

United States1 site
  • Maimonides Medical Center

    New York, New York

    Completed

Other trials in United States

Israel1 site, 1 recruiting
  • bnai-Zion Medical center

    Haifa

    RON GONEN, Prof.

    Recruiting

Other trials in Israel

About this study

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.

Read the 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.

Conditions
Pregnancy, Labor
Being tested
LaborPro device
Keywords
active stage, labor, progression, pregnant woman during active phases of labor
Medical subject headings
Disease Progression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LaborPro deviceDevice

    Also called LaborPro TrigMedical

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 1 year

Secondary outcomes (1)
  1. 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionFeb 2010 (estimated)
  4. Study completionFeb 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Investigator
Enrolment
650 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00827125
Sponsor's protocol ID
CLP 032/2008CTIL
Status last verified
Jan 2009
First submitted
21 Jan 2009
Last updated
5 Jan 2010
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 32120420

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LaborPro device in people with Pregnancy and Labor, run by Trig Medical Inc at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tzipi Yakoby, Director of Clinical Marketing (+972-4-9597930, tzipi@TrigMed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of the LaborPro as a prediction tool of labor progression. by introducing extended labor curves. (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00827125, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2010.

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