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

January 21, 2009 updated by: Trig Medical Inc
A clinical study was conducted to demonstrate the accuracy of the LaborPro System in measuring fetal head station (from the pelvic inlet), cervical dilatation, and fetal head position against manual/digital examination. The LaborPro obtained device values was compared to measurements gathered within 15 minutes by manual/digital examination performed by two independent physicians. The study was a non significant risk (NSR) device study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Objective The purpose of the study was to evaluate the accuracy of LaborPro fetal head station, fetal head position, and cervical dilatation measurements as compared to manual/digital examinations and to demonstrate that the LaborPro System is safe.

Methods and Procedures The study population included of women admitted to either Maimonides Medical Center (NY, USA) or Bnai Zion Medical Center (Haifa, Israel) in the active phase of labor, with singleton pregnancy and vertex presentation. One hundred and ten (110) subjects were enrolled in the study. Two subjects were excluded from the study as one from Bnai Zion Medical Center had a system malfunction (PC failure) and one subject from Maimonides Medical Center changed her mind and refused to participate in the study. Sixty Seven (67) subjects (62%) were enrolled at Maimonides Medical Center and forty one (41) subjects (38%) were enrolled at Bnai Zion Medical Center. Subject's mean age was 28.2 years (ranging from 15.8 years to 39.5).

Each subject was examined and in cases in which the first exam (according to blinded physician assessment) was at an early labor stage (cervical dilatation < 3 cm), a second examination interval of at least 2 hours after the first one was recorded. In cases where the first examination was performed at a more advanced labor stages (cervical dilatation > 3 cm), a second examination interval was recorded at least 1 hour after the first one. Each set of examinations (LaborPro and two independent practitioners) of station, position and cervical dilatation was completed within 15 minutes. The two independent physicians were blinded to each other's results and to the LaborPro results. If labor duration enabled further examination, two to three sets of tests were performed for each subject. During labor, the attending physician, a midwife or nurse conducted manual trans-vaginal digital evaluations (TVDEs) according to standard practice with respect to frequency and method.

During the manual TVDE, the clinician used the LaborPro finger sensor so that simultaneous LaborPro measurements of fetal head station finger tip (HSFT) and cervical dilatation (CDFT) were recorded. A trained ultrasonographer (physician, midwife or technician) also performed an ultrasound examination to yield the LaborPro data for measurements of head position (HP) and the head station (HSUS) with respect to BPD vs. Pelvic Inlet or with respect to fetal scalp tip vs. Pelvic Inlet.

Study Endpoints Primary Endpoint The primary efficacy endpoints of the study are average differences between measurements of Head Station (HS) and Cervical Dilatation (CD) made by the device (LaborPro) and by TVDEs.

Secondary Endpoint The secondary efficacy endpoint is the degree of agreement between the Fetal Head Position (HP) measured by LaborPro versus the one measured by TVDE.

In summary, the labor parameters as measured by LaborPro compared to the gold-standard physicians' assessment result in an accurate representation of fetal head station (calculated from the pelvic inlet), cervical dilatation, and fetal head position. It therefore can be concluded that the LaborPro provides a clinically and statistically adequate estimate of the fetal head station (calculated from the pelvic inlet), fetal head position, and cervical dilatation. The safety profile of the LaborPro non invasive system is also demonstrated by the non occurrence of any device related adverse event.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Active phase of labor
  • Singleton pregnancy (as diagnosed by ultrasound)
  • Cephalic presentation

Exclusion Criteria:

  • Known or suspected disease of mother or fetus from among the following:
  • Positive HIV testing
  • Positive Hepatitis B Surface Antigen testing
  • Active Genital Herpes Simplex
  • Coagulation disorders
  • Fetal distress
  • Inability to provide informed consent or comply with study protocol
  • Abnormal placentation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: LaborPro, active Labor, Vaginal Examination
Device: Labor Monitor

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Trig Medical Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLP 019/2008CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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