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
  Purpose

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


Condition
Pregnancy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Electrohysterogram-based Sensor for Non-Invasive Contraction Monitoring With Improved Reliability

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

Estimated Enrollment: 100
Study Start Date: July 2011
Detailed Description:

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.

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

Locations
United States, Florida
University of Florida College of Medicine Recruiting
Gainesville, Florida, United States, 32611
Contact: Anthony Gregg, MD     352-273-7562        
Sponsors and Collaborators
Convergent Engineering, Inc.
Investigators
Principal Investigator: Anthony Gregg, PhD University of Florida
  More Information

No publications provided

Responsible Party: Anthony Gregg, MD, University of Florida College of Medicine
ClinicalTrials.gov Identifier: NCT01400880     History of Changes
Other Study ID Numbers: Conveng-001
Study First Received: July 21, 2011
Last Updated: July 21, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013