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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00827229
Recruitment Status : Completed
First Posted : January 22, 2009
Last Update Posted : January 22, 2009
Information provided by:
Trig Medical Inc

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Labor Device: Labor Monitor Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Study Start Date : January 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Arm Intervention/treatment
LaborPro, active Labor, Vaginal Examination Device: Labor Monitor

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Responsible Party: Yoav paltieli CEO, Trigmedical Identifier: NCT00827229     History of Changes
Other Study ID Numbers: CLP 019/2008CTIL
First Posted: January 22, 2009    Key Record Dates
Last Update Posted: January 22, 2009
Last Verified: January 2009

Keywords provided by Trig Medical Inc:
Active labor
Term pregnancy
Vertex presentation
Single fetus