Electrohysterogram-based Sensor for Non-Invasive Contraction Monitoring With Improved Reliability
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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 |
| Estimated Enrollment: | 100 |
| Study Start Date: | July 2011 |
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 |
Laboring women in Labor and Delivery ward
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| United States, Florida | |
| University of Florida College of Medicine | Recruiting |
| Gainesville, Florida, United States, 32611 | |
| Contact: Anthony Gregg, MD 352-273-7562 | |
| 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 23, 2013