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Trial record 2 of 2 for:    obmedical

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

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ClinicalTrials.gov Identifier: NCT02024165
Recruitment Status : Completed
First Posted : December 31, 2013
Results First Posted : May 12, 2015
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
OBMedical Company

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
Laboring Women With Ultrasound and FSE Monitoring

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.


Study Type : Observational
Actual Enrollment : 71 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Electrode-Based Sensor for Non-Invasive Fetal Heart Rate Monitoring With Improved Reliability
Study Start Date : November 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort
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
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



Primary Outcome Measures :
  1. Fetal Heart Rate Interpretability [ Time Frame: 2 hours ]
    The Fetal Heart Rate (or FHR) of the electrode sensor will be compared to the FHR of the ultrasound when both are compared to the FSE. Percentage of time that signals are interpretable will be compared between devices



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Laboring women in Labor and Delivery Ward
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02024165


Locations
United States, Florida
Winnie Palmer Hospital for Women and Babies
Orlando, Florida, United States, 32806
Sponsors and Collaborators
OBMedical Company
Investigators
Principal Investigator: John Busowski, MD Winnie Palmer Hospital for Women and Babies

Responsible Party: OBMedical Company
ClinicalTrials.gov Identifier: NCT02024165     History of Changes
Other Study ID Numbers: OBM-WP-2013
IRB ( Other Identifier: 510126-1 )
First Posted: December 31, 2013    Key Record Dates
Results First Posted: May 12, 2015
Last Update Posted: May 12, 2015
Last Verified: April 2015

Keywords provided by OBMedical Company:
Ultrasound
FSE
IUPC