Electrohysterogram-based Sensor for Non-Invasive Contraction Monitoring With Improved Reliability

This study is currently recruiting participants.
Verified July 2011 by Convergent Engineering, Inc.
Sponsor:
Information provided by:
Convergent Engineering, Inc.
ClinicalTrials.gov Identifier:
NCT01400880
First received: July 21, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted

July 21, 2011
July 21, 2011
July 2011
Not Provided
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Electrohysterogram-based Sensor for Non-Invasive Contraction Monitoring With Improved Reliability
Electrohysterogram-based Sensor for Non-Invasive Contraction Monitoring With Improved Reliability

The purpose of this research study is to determine whether the investigators can monitor maternal contractions noninvasively by measuring uterine muscle activity.

The majority of obstetric deliveries in the US undergo electronic monitoring and continuous uterine activity monitoring is the standard of care. Typically, an external tocodynamometer (strain gauge, toco for short) is employed to provide the frequency and timing of uterine contractions. The reliability of this monitor depends on its proper positioning (which may be disturbed by patient movement), and the transmission of tension from the uterus to the sensor. In some patients, particularly the obese, the monitor may fail to detect contractions consistently. In others the monitor requires frequent repositioning by the nursing staff. 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, as well as quantitative information regarding intrauterine pressure, its invasive nature and increased risk of infection limit enthusiasm for its use.

Obesity 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 uterine activity monitoring, while preferable to reduce the infection risk, is particularly unreliable in this population.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Laboring women in Labor and Delivery ward

Pregnancy
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
Not Provided

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
Female
18 Years to 50 Years
Yes
Not Provided
United States
 
NCT01400880
Conveng-001
No
Anthony Gregg, MD, University of Florida College of Medicine
Convergent Engineering, Inc.
Not Provided
Principal Investigator: Anthony Gregg, PhD University of Florida
Convergent Engineering, Inc.
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP