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Clinical Trials/NCT01400880
NCT01400880
Completed
Early Phase 1

Electrode-based Sensor for Non-invasive Fetal Heart Rate and EMG Monitoring With Improved Reliability

Convergent Engineering, Inc.1 site in 1 country103 target enrollmentJuly 1, 2011
ConditionsPregnancy

Overview

Phase
Early Phase 1
Intervention
Electrode-based Sensor
Conditions
Pregnancy
Sponsor
Convergent Engineering, Inc.
Enrollment
103
Locations
1
Primary Endpoint
Comparison of Electrode Sensor and TOCO Detection of Contraction Events, as Compared to IUPC
Status
Completed
Last Updated
25 days ago

Overview

Brief Summary

The specific goal of the proposed research is to develop a reliable, non-invasive fetal and maternal heart rate and contraction monitor that is unaffected by obesity and requires less nursing intervention than the tocodynamometer and Doppler ultrasound.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2011
End Date
April 1, 2014
Last Updated
25 days ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Women between the ages of 18 and 50 years old
  • \>/= 34 weeks gestation
  • Single viable fetus in cephalic presentation

Exclusion Criteria

  • Bleeding or uterine scarring

Arms & Interventions

Pregnant

In Labor

Intervention: Electrode-based Sensor

Outcomes

Primary Outcomes

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.

Study Sites (1)

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