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

• ClinicalTrials.gov Identifier: NCT01400880
• Recruitment Status: Completed
• First Posted: July 22, 2011
• Results First Posted: February 12, 2015
• Last Update Posted: February 12, 2015
• Sponsor: Convergent Engineering, Inc.
• Information provided by (Responsible Party): Convergent Engineering, Inc.

Study Description

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.

Condition or disease
Pregnancy

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 103 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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

Groups and Cohorts

Group/Cohort
Pregnant; In Labor

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes 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

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

• Responsible Party: Convergent Engineering, Inc.
• ClinicalTrials.gov Identifier: NCT01400880
• Other Study ID Numbers: Conveng-001
• First Posted: July 22, 2011
• Results First Posted: February 12, 2015
• Last Update Posted: February 12, 2015
• Last Verified: February 2015

Keywords provided by Convergent Engineering, Inc.:

Maternal Fetal Monitoring