LaborNCT00827229
Evaluation of Laborpro - a New Device for the Assessment of Progress of Labor
A study testing Labor Monitor in people with Labor, run by Trig Medical Inc.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor
- What is being tested?
- Labor Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Dec 2007
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Active phase of labor
- Singleton pregnancy (as diagnosed by ultrasound)
- Cephalic presentation
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Labor
- Being tested
- Labor Monitor
- Keywords
- Active labor, Term pregnancy, Vertex presentation, Single fetus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labor MonitorDevice
| Study group | Role | What they receive |
|---|---|---|
| LaborPro, active Labor, Vaginal Examination | Other | Not described Receives: Device: Labor Monitor |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startJan 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trig Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827229
- Sponsor's protocol ID
- CLP 019/2008CTIL
- Status last verified
- Jan 2009
- First submitted
- 21 Jan 2009
- Last updated
- 22 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Laborpro - a New Device for the Assessment of Progress of Labor
- ClinicalTrials.gov ID
- NCT00827229
- Acronym / sponsor ID
- CLP 019/2008CTIL
- Conditions
- Labor
- Keywords
- Active labor, Term pregnancy, Vertex presentation, Single fetus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Trig Medical IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 22 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LaborPro, active Labor, Vaginal Examination | Other | Device: Labor Monitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Active phase of labor
- Singleton pregnancy (as diagnosed by ultrasound)
- Cephalic presentation
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Labor Monitor | Device | LaborPro, active Labor, Vaginal Examination |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Labor Monitor in people with Labor, run by Trig Medical Inc.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 22 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 22 Jan 2009.