Electrohysterogram-based Sensor for Non-Invasive Contraction Monitoring With Improved Reliability
| Tracking Information | |||||
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| First Received Date ICMJE | July 21, 2011 | ||||
| Last Updated Date | July 21, 2011 | ||||
| Start Date ICMJE | July 2011 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | No Changes Posted | ||||
| 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 | Electrohysterogram-based Sensor for Non-Invasive Contraction Monitoring With Improved Reliability | ||||
| Official Title ICMJE | Electrohysterogram-based Sensor for Non-Invasive Contraction Monitoring With Improved Reliability | ||||
| Brief Summary | The purpose of this research study is to determine whether the investigators can monitor maternal contractions noninvasively by measuring uterine muscle activity. |
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| Detailed Description | The majority of obstetric deliveries in the US undergo electronic monitoring and continuous uterine activity monitoring is the standard of care. Typically, an external tocodynamometer (strain gauge, toco for short) is employed to provide the frequency and timing of uterine contractions. The reliability of this monitor depends on its proper positioning (which may be disturbed by patient movement), and the transmission of tension from the uterus to the sensor. In some patients, particularly the obese, the monitor may fail to detect contractions consistently. In others the monitor requires frequent repositioning by the nursing staff. The alternative uterine activity monitor is an intrauterine pressure catheter (IUPC), which is placed through the cervical os in the adequately dilated patient with ruptured membranes. While this monitor usually provides a more reliable signal, as well as quantitative information regarding intrauterine pressure, its invasive nature and increased risk of infection limit enthusiasm for its use. Obesity is an ever-increasing problem in the US, and is even more prominent in the obstetric suite. Meanwhile, obese women have an increased risk for labor problems, infections and other complications. Noninvasive uterine activity monitoring, while preferable to reduce the infection risk, is particularly unreliable in this population. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Laboring women in Labor and Delivery ward |
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| Condition ICMJE | Pregnancy | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| 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 | 100 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 50 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01400880 | ||||
| Other Study ID Numbers ICMJE | Conveng-001 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Anthony Gregg, MD, University of Florida College of Medicine | ||||
| Study Sponsor ICMJE | Convergent Engineering, Inc. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Convergent Engineering, Inc. | ||||
| Verification Date | July 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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