Electrode-Based Sensor for Non-Invasive Fetal Heart Rate Monitoring With Improved Reliability

NCT ID: NCT02024165

Last Updated: 2015-05-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 71 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-04-30

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.

Maternal obesity (defined as BMI at presentation ≥ 30) 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 labor monitoring, while preferable to reduce the infection risk, is particularly unreliable in this population.

Conditions

Laboring Women With Ultrasound and FSE Monitoring

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Electrode Sensor, FSE

Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor, and/or FSE

No interventions assigned to this group

Electrode Sensor, Ultrasound

Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor, and/or Ultrasound

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Parturients presenting to Labor & Delivery for labor at term (>36 weeks completed gestation)
• Single viable fetus in cephalic presentation
• With FSE or IUPC for obstetric indications

Exclusion Criteria

• Multi fetal gestation
• Contraindication to FSE or IUPC placement
• Insufficient abdominal space for all required sensors

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

OBMedical Company

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Busowski, MD

Role: PRINCIPAL_INVESTIGATOR

Winnie Palmer Hospital for Women and Babies

Locations

Winnie Palmer Hospital for Women and Babies

Orlando, Florida, United States

Countries

United States

Other Identifiers

IRB

Identifier Type: OTHER

Identifier Source: secondary_id

OBM-WP-2013

Identifier Type: -

Identifier Source: org_study_id