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Completed

NCT Number: NCT03899493

Electromyography in Labor and Parturition

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.

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Key information

Conditions

Labor

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

Multichannel Surface Electromyography in Labor and Parturition

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 2, 2019
Registry last updated
May 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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