Electromyography in Labor and Parturition

NCT03899493 | Completed

• 1 other identifier: 1809958902
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor

Keywords

Electroencephalography; Electromyography; Pelvic Floor; Labor curve; Intrauterine infection; Hypertensive Disorders of Pregnancy

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Primiparous & Multiparous

Women having borne at least one child \> 20 weeks gestational age

Other: Observation

Nulliparous

Women in whom this is their first pregnancy \> 20 weeks who are anticipated to deliver

Other: Observation

Interventions

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.

Nulliparous; Primiparous & Multiparous

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

Related Publications (5)

• 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

  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.

  PMID: 27436367 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.

  PMID: 24187578 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.

  PMID: 26575523 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.

  PMID: 29297950 RESULT

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Mike Foley, MD

  BUMCP, Chair Department of Obstetrics and Gynecology

  STUDY CHAIR

• Kendra Gray, DO

  Banner University Medical Center, MFM Fellow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maternal Fetal Medicine Fellow

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: April 2, 2019
• Study Start: April 29, 2019
• Primary Completion: May 4, 2021
• Study Completion: May 4, 2021
• Last Updated: May 6, 2021

Record last verified: 2021-05

Locations

US (1)