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Clinical Feasibility of Computerized Labor Monitor (CLM) -Heart Application (HA)

Feasibility Study -Clinical Feasibility of Computerized Labor Monitor (CLM) -Heart Application

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00502918
Enrollment
3
Registered
2007-07-18
Start date
2008-02-29
Completion date
2008-08-31
Last updated
2009-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor, Obstetrics

Brief summary

The study is a feasibility study to check the possibility of tracking the heart rate of the fetus and to translate the outcome to the progress of the labor

Detailed description

Every year, millions of babies are born worldwide. Yet, despite great advances in medical technology, the method used to obtain the most critical parameter in labor management - cervix dilatation, remains a vaginal (manual) examination. This vaginal examination, intended to estimate the dilatation of the cervix and the progress of the baby's head, is inaccurate, non-continuous and involves the risk of infection to both fetus and mother. It is also uncomfortable to the mother. The consequences of infections or delayed treatment may range from simple complications to irreversible damage. Early detection of abnormal patterns of labor progress could prevent complications and shorten the labor process and hospitalization, thereby saving both aggravation and cost. To truly manage the labor process, a labor management system is required. Such a system is expected to provide the obstetrical staff with the flow of accurate, continuous, real-time information, such as cervix dilatation.

Interventions

DEVICECLM - HA Continuous Monitoring System Heart Application

Sponsors

Barnev Ltd
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

1. Laboring women refered to the maternity center in active labor (3cm dilatation and contraction) 2. Gestational age 37-42 weeks. (GA) 3. Single Fetus. 4. Subjects who understand, agreed and signed the informed consent form.

Exclusion criteria

1. Women with abnormal placentation (Placenta previa) - 2. Abnormal fetal presentation (Breech presentation). 3. Maternal History of HIV and/or blood transmitted Hepatitis and /or active genital Herpes. 4. Need for immediate delivery (cord prolapsed or suspected placental abruption)

Design outcomes

Primary

MeasureTime frame
Monitoring fetal heart movementDuring labour

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026