Labor Progress Indices and the Dynamics of the Individual Contraction During the Active Stage of Labor
Recruitment status was Recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | October 20, 2009 | ||||||||
| Last Updated Date | July 17, 2012 | ||||||||
| Start Date ICMJE | September 2010 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Birth Track measurements versus manual measurements [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01009411 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 | Labor Progress Indices and the Dynamics of the Individual Contraction During the Active Stage of Labor | ||||||||
| Official Title ICMJE | Physiological Study of the Active Stage of Labor | ||||||||
| Brief Summary | Objective of the study: to obtain new data on the dynamics of the labor process, cervix dilatation and head station on the labor process and to develop a new progress indices. Background: the best method used today to supervise the labor process is to follow cervix dilatation and head station. Today, the physician or the midwife use manual examination to estimate cervix dilatation and head station. This examination is perform many times in a normal labor process, and even more if there is any delay. The information from these examinations is inaccurate and non-continuous. In case of delay in the labor process, the delay will diagnosed late, because the frequency of the manual examination is about once an hour. With the assistance of the BirthTrack device we can get continuous data on the labor process and get indices to estimate the labor process progress without the use of vaginal (manual) examination. 40 women in an active labor will take part in the study. Method: by connecting sensors to the woman abdomen, to the cervix and to the baby head we follow the cervix dilatation and the fetus head station. |
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| Detailed Description | Not Provided | ||||||||
| 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 | Nulliparous women over 18 years admitted to the labor in active labor |
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| Condition ICMJE | Labor | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Estimated Completion Date | December 2012 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 40 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01009411 | ||||||||
| Other Study ID Numbers ICMJE | BT-1-IS-001 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Prof. Jacob Bornstein, Western Galilee Hospital-Nahariya | ||||||||
| Study Sponsor ICMJE | Western Galilee Hospital-Nahariya | ||||||||
| Collaborators ICMJE | Barnev Ltd | ||||||||
| Investigators ICMJE |
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| Information Provided By | Western Galilee Hospital-Nahariya | ||||||||
| Verification Date | May 2011 | ||||||||
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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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