Clinical Feasibility of Computerized Labor Monitor (CLM) -Heart Application (HA)
| Tracking Information | |||||
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| First Received Date ICMJE | July 17, 2007 | ||||
| Last Updated Date | December 27, 2009 | ||||
| Start Date ICMJE | February 2008 | ||||
| Estimated Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Monitoring fetal heart movement [ Time Frame: During labour ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00502918 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Clinical Feasibility of Computerized Labor Monitor (CLM) -Heart Application (HA) | ||||
| Official Title ICMJE | Feasibility Study -Clinical Feasibility of Computerized Labor Monitor (CLM) -Heart Application | ||||
| 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 |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Laboring women reffered to the maternity center in active labor (3cm - 7 cm) dilataion and contraction |
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| Condition ICMJE |
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| Intervention ICMJE | Device: CLM - HA Continuous Monitoring System Heart Application
NA |
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| Study Group/Cohort (s) | 1
Intervention: Device: CLM - HA Continuous Monitoring System Heart Application |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 3 | ||||
| Completion Date | August 2008 | ||||
| Estimated Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 20 Years to 50 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00502918 | ||||
| Other Study ID Numbers ICMJE | TASMC-07-AM-279-CTIL | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Clinical Trial Manager, Barnev Ltd | ||||
| Study Sponsor ICMJE | Barnev Ltd | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Barnev Ltd | ||||
| Verification Date | July 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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