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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Convergent Engineering, Inc.
ClinicalTrials.gov Identifier:
NCT01400880
First received: July 21, 2011
Last updated: February 10, 2015
Last verified: February 2015
  Purpose

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.


Condition
Pregnancy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Electrode-based Sensor for Non-invasive Fetal Heart Rate and EMG Monitoring With Improved Reliability

Further study details as provided by Convergent Engineering, Inc.:

Primary Outcome Measures:
  • Comparison of Electrode Sensor and TOCO Detection of Contraction Events, as Compared to IUPC [ Time Frame: Stage I and II Labor ] [ Designated as safety issue: No ]
    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.


Enrollment: 103
Study Start Date: July 2011
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pregnant
In Labor

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Laboring women in Labor and Delivery ward

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01400880

Locations
United States, Florida
University of Florida College of Medicine
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
Convergent Engineering, Inc.
Investigators
Principal Investigator: Anthony Gregg, PhD University of Florida
  More Information

No publications provided

Responsible Party: Convergent Engineering, Inc.
ClinicalTrials.gov Identifier: NCT01400880     History of Changes
Other Study ID Numbers: Conveng-001
Study First Received: July 21, 2011
Results First Received: September 9, 2014
Last Updated: February 10, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Convergent Engineering, Inc.:
Maternal Fetal Monitoring

ClinicalTrials.gov processed this record on April 16, 2015