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This study will examine how the uterus, abdominal wall, pelvic floor and brain interact during labor and parturition. It will uses electromyography (EMG) to compare the characteristics of the uterus, abdominal wall and perineum in subjects with and without various pregnancy characteristics.
EMG will help established burst frequency and characteristics of the uterus compared to other parts of the body during labor and delivery. Other parts of the body may include abdominal surfaces (for uterine, abdominal, maternal EMG and fetal heart rate monitoring), perineal surface (for perineal muscles monitoring) and the maternal scalp (brain monitoring). EEG measures the electrical activity of the brain. The activity is recorded using wire electrodes attached to the scalp or mounted on a cap placed on the head. E MG measures electrical activity from muscles. It uses wire electrodes placed on the skin over the muscles.
Pregnant adult volunteers and patients who present to the investigator's institution may be eligible for this study.
Participants will lay or sit in a semi-reclining chair with sticker electrodes placed on the body surface area of interest. Muscle and/or brain activity will be measured with EEG and EMG recordings.
Objectives
Study Population:
Pregnant volunteers greater than 18 years of age who speak English.
Design:
During the course of the participant's admission, they will be dispositioned to usual obstetric care which may include minimal intervention if spontaneous labor, induction of labor or augmentation of labor as indicated. As part of the study protocol, enrolled participants will be monitored with external sensors/transducers. The device will be attached to a patient's body, which may include the abdominal surface, perineal surface and the mother's scalp by trained study staff through electrical leads that are connected to commercially available EMG or EEG electrodes that have adhesive material in contact with the surface of the patient. Recordings will be made at specific times during labor
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primiparous & Multiparous | Women having borne at least one child > 20 weeks gestational age |
| |
| Nulliparous | Women in whom this is their first pregnancy > 20 weeks who are anticipated to deliver |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation | Other | Patients will be dispositioned to usual obstetric care which may include minimal intervention if spontaneous labor, induction of labor or augmentation of labor as indicated and dictated by the participants obstetrical provider. This study is observational only. |
| Measure | Description | Time Frame |
|---|---|---|
| Burst Characteristic RMS | EEG and EMG burst characteristics will be measured as RMS value (mV). | Through study completion, an average of 3 years |
| Burst Characteristic Median Frequency | EEG and EMG burst characteristics will be measured as median frequency (Hz). | Through study completion, an average of 3 years |
| Burst Characteristic Duration | EEG and EMG burst characteristics will be measured as duration (seconds). | Through study completion, an average of 3 years |
| Burst Characteristics Amplitude | EEG and EMG burst characteristics will be measured as amplitude (mV). | Through study completion, an average of 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients eligible for inclusion in this study protocol will be aged 18 years-old and older, female, and pregnant. There will be no restrictions based on race or ethnic group beyond exclusion of non-English-speaking patients.
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| Name | Affiliation | Role |
|---|---|---|
| Mike Foley, MD | BUMCP, Chair Department of Obstetrics and Gynecology | Study Chair |
| Kendra Gray, DO | Banner University Medical Center, MFM Fellow | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center Phoenix | Phoenix | Arizona | 85006 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Creasy R, Resnik R, Iams J, Lockwood C, Moore T, Greene M. Creasy and Resnik's Maternal-Fetal Medicine, 7th Edition.; 2014. doi:10.1016/B978-1-4557-1137-6.00062-3 | ||
| 27436367 | Result | Qian X, Li P, Shi SQ, Garfield RE, Liu H. Simultaneous Recording and Analysis of Uterine and Abdominal Muscle Electromyographic Activity in Nulliparous Women During Labor. Reprod Sci. 2017 Mar;24(3):471-477. doi: 10.1177/1933719116658704. Epub 2016 Jul 19. | |
| 24187578 |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| Result |
| Lucovnik M, Kuon RJ, Garfield RE. Assessment of parturition with cervical light-induced fluorescence and uterine electromyography. Comput Math Methods Med. 2013;2013:165913. doi: 10.1155/2013/165913. Epub 2013 Sep 29. |
| 26575523 | Result | Trojner Bregar A, Lucovnik M, Verdenik I, Jager F, Gersak K, Garfield RE. Uterine electromyography during active phase compared with latent phase of labor at term. Acta Obstet Gynecol Scand. 2016 Feb;95(2):197-202. doi: 10.1111/aogs.12818. Epub 2015 Dec 8. |
| 29297950 | Result | Lucovnik M, Trojner Bregar A, Bombac L, Gersak K, Garfield RE. Effects of vaginal progesterone for maintenance tocolysis on uterine electrical activity. J Obstet Gynaecol Res. 2018 Mar;44(3):408-416. doi: 10.1111/jog.13545. Epub 2018 Jan 3. |