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Electromyography in Labor and Parturition

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ClinicalTrials.gov Identifier: NCT03899493
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Kendra Gray, DO, University of Arizona

Brief Summary:

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.


Condition or disease Intervention/treatment
Labor Other: Observation

Detailed Description:

Objectives

  • To define the relationship between uterine electrical activity EMG during labor and parturition to various phases of labor and cervical dilations.
  • To define the relationship between uterine and body site electrical activity EMG and brain EEG during labor and parturition in patient with hypertensive disorders of pregnancy
  • To characterize electrical activity of pelvic floor muscles in relationship to uterine and abdominal muscles during delivery between subsets of patients
  • To examine the electrical activity of women in preterm labor and those with labor dystocias to observe the effects of various treatments, which may have an impact on preventing or augmenting labor progress.
  • To observe the impact of naturally occurring pregnancy pathology and common obstetrical interventions on the changes in uterine, abdominal, pelvic floor and brain EEG/EMG characteristics as compared to health normal gravid patients.

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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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Multichannel Surface Electromyography in Labor and Parturition
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Childbirth

Group/Cohort Intervention/treatment
Primiparous & Multiparous
Women having borne at least one child > 20 weeks gestational age
Other: Observation
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.

Nulliparous
Women in whom this is their first pregnancy > 20 weeks who are anticipated to deliver
Other: Observation
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.




Primary Outcome Measures :
  1. Burst Characteristic RMS [ Time Frame: Through study completion, an average of 3 years ]
    EEG and EMG burst characteristics will be measured as RMS value (mV).

  2. Burst Characteristic Median Frequency [ Time Frame: Through study completion, an average of 3 years ]
    EEG and EMG burst characteristics will be measured as median frequency (Hz).

  3. Burst Characteristic Duration [ Time Frame: Through study completion, an average of 3 years ]
    EEG and EMG burst characteristics will be measured as duration (seconds).

  4. Burst Characteristics Amplitude [ Time Frame: Through study completion, an average of 3 years ]
    EEG and EMG burst characteristics will be measured as amplitude (mV).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Pregnant women admitted to the Labor & Delivery unit at Banner University Medical Center - Phoenix for either (a) labor or (b) induction of labor.
  • Age > 18 years-old
  • No contraindications to vaginal delivery

Exclusion Criteria:

  • Non-English-speaking patients
  • Known uterine abnormalities that may affect the normal contractility of the uterus.

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): NCT03899493


Contacts
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Contact: Kendra M Gray, DO 4802723555 kendra_gray@mednax.com
Contact: Regina Montero, MSN 480-239-8697 rmontero52@email.arizona.edu

Locations
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United States, Arizona
Banner University Medical Center Phoenix Recruiting
Phoenix, Arizona, United States, 85006
Contact: Regina Montero, MSN    480-239-8697    rmontero@email.arizona.edu   
Contact: Elena Young, MS, CCRP    602-827-9963    elenay@email.arizona.edu   
Principal Investigator: Kendra M Gray, DO         
Sub-Investigator: Michael Leovic, MD         
Sub-Investigator: Roman Starikov, MD         
Principal Investigator: Robert Garfield, PhD         
Sponsors and Collaborators
University of Arizona
Investigators
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Study Chair: Mike Foley, MD BUMCP, Chair Department of Obstetrics and Gynecology
Principal Investigator: Kendra Gray, DO Banner University Medical Center, MFM Fellow

Additional Information:

Publications of Results:
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Responsible Party: Kendra Gray, DO, Maternal Fetal Medicine Fellow, University of Arizona
ClinicalTrials.gov Identifier: NCT03899493     History of Changes
Other Study ID Numbers: 1809958902
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kendra Gray, DO, University of Arizona:
Electroencephalography
Electromyography
Pelvic Floor
Labor curve
Intrauterine infection
Hypertensive Disorders of Pregnancy