Electrode-based Sensor for Non-invasive Fetal Heart Rate and EMG Monitoring With Improved Reliability
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|ClinicalTrials.gov Identifier: NCT01400880|
Recruitment Status : Completed
First Posted : July 22, 2011
Results First Posted : February 12, 2015
Last Update Posted : February 12, 2015
|Condition or disease|
The majority of obstetric deliveries in the US undergo electronic monitoring and continuous uterine activity and fetal heart rate (FHR) monitoring is the standard of care. Typically, external transducers are employed, the reliability of which depends on their proper positioning, which may be disturbed by patient or fetal movement. The tocodynamometer (strain gauge, toco for short) provides frequency and timing of contractions, but requires transmission of tension from the uterus to the sensor. Fetal heart rate is acquired with an external Doppler ultrasound transducer. The reliability of this monitor depends on the ability to obtain a window to the fetal heart.
In some patients, particularly the obese, the toco and ultrasound may fail to monitor consistently. In others both transducers require frequent repositioning by the nursing staff, and the Doppler may erroneously report maternal heart rate instead of fetal.
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 than the toco, as well as quantitative information regarding intrauterine pressure, it is invasive and there is an increased risk of infection. The alternative FHR monitor is via fetal scalp electrode (FSE), which is applied transvaginally to the fetal presenting part, also requiring adequate cervical dilation and ruptured membranes. While the FSE usually provides a more reliable signal, it is similarly invasive and increases risk of infection.
|Study Type :||Observational|
|Actual Enrollment :||103 participants|
|Official Title:||Electrode-based Sensor for Non-invasive Fetal Heart Rate and EMG Monitoring With Improved Reliability|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
- Comparison of Electrode Sensor and TOCO Detection of Contraction Events, as Compared to IUPC [ Time Frame: Stage I and II Labor ]Contraction timing as measured by the electrode sensor and contraction timing as measure by the TOCO, both compared to the contraction timing as measured by the IUPC gold standard. The contraction timing values of the electrode sensor and TOCO were then compared.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01400880
|United States, Florida|
|University of Florida College of Medicine|
|Gainesville, Florida, United States, 32611|
|Principal Investigator:||Anthony Gregg, PhD||University of Florida|