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Spontaneous Fetal EEG Recording During Labor

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ClinicalTrials.gov Identifier: NCT03013569
Recruitment Status : Recruiting
First Posted : January 6, 2017
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Martin Frasch, University of Washington

Tracking Information
First Submitted Date January 4, 2017
First Posted Date January 6, 2017
Last Update Posted Date September 6, 2019
Study Start Date January 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 7, 2017)
Recording spontaneous EEG during labor [ Time Frame: 12 month recruitment period ]
The investigators will record spontaneous fetal EEG activity during labor using a custom-build IRB-approved fetal EEG device. The validity of the recorded data will be analyzed based on the physiological characteristics of the data such as amplitude and frequency properties as well as the behavioral state architecture (duration of low voltage/high frequency and high voltage/low frequency states as well as of the indeterminate states). The data will be analyzed in conjunction with the accompanying fetal heart rate recordings which also show behavioral state fluctuations.
Original Primary Outcome Measures
 (submitted: January 5, 2017)
  • Recording spontaneous EEG during labor [ Time Frame: 12 month recruitment period ]
    The investigators will record spontaneous fetal EEG activity during labor using a custom-build IRB-approved fetal EEG device. The validity of the recorded data will be analyzed based on the physiological characteristics of the data such as amplitude and frequency properties as well as the behavioral state architecture (duration of low voltage/high frequency and high voltage/low frequency states as well as of the indeterminate states). The data will be analyzed in conjunction with the accompanying fetal heart rate recordings which also show behavioral state fluctuations.
  • Fetal acidemia [ Time Frame: 12 month recruitment period ]
    EEG recordings will be used to validate whether the EEG-FHR patterns are predictive of fetal acidemia intrapartum
Change History Complete list of historical versions of study NCT03013569 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 7, 2017)
Fetal acidemia [ Time Frame: 12 month recruitment period ]
EEG recordings will be used to validate whether the EEG-FHR patterns are predictive of fetal acidemia intrapartum
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Spontaneous Fetal EEG Recording During Labor
Official Title Can Spontaneous Fetal EEG Be Recorded During Labor Using the Established Fetal Scalp Electrode Heart Rate Monitoring System?
Brief Summary This is a pilot feasibility study for a new application of an approved fetal heart rate monitoring device system. The objective of this study is to validate the feasibility of acquiring the new modality of human fetal bioelectrical activity, EEG, derived from the routinely used scalp fetal heart rate (FHR) monitor.
Detailed Description

The investigators' objective is to validate the feasibility of acquiring the new modality of human fetal bioelectrical activity, EEG, derived from the routinely used scalp FHR monitor.

The investigators expect that in some newborns acidemia will be detected based on cord blood pH. In these babies, the investigators will trace back the EEG recordings to further validate whether the EEG - FHR patterns were predictive of this outcome. In fetal sheep model of human labour the investigators were able to see the onset of acidemia <55 min ahead of severe drop of pH to <7.00. This corresponded to an average pH of 7.20.

The investigators hypothesize that they will be able to acquire fetal EEG during labour such that the normal behavioural sleep states will be observed and their disruption, followed by emergence of the pathognomonic EEG-FHR pattern will be seen with incipient acidemia.

At-risk pregnant women routinely admitted for intrapartum monitoring will be asked to consent when the Fetal Scalp Monitor (FSM) is placed. The attachment will be such that no direct contact to mother or baby will be established and hence no current from device to the mother or the baby will be possible. The EEG fetal health monitoring device is attached to the routinely used fetal heart rate (FHR) GE HC Corometrix 250cx monitor. The EEG recording will commence only once the FSM is attached; the attachment of the FSM will be performed based on medical necessity, not based on the need to record EEG.

Duration of recording will be dependent on the labour duration. However, the investigators will seek for a minimum of 30 minutes and continue as long as medically possible per subject.

Fetal EEG will be analyzed as published. The quickest reference to the analytical approach is given here: http://dx.doi.org/10.1371/journal.pone.0108119.g001

Cord blood gas at delivery will be recorded from electronic medical record, as it is taken routinely at birth. Basic maternal and neonatal clinical characteristics (BMI, APGAR scores, number of pregnancies and live births, maternal and fetal ages at birth), will also be taken from the medical record.

b. Experience and preliminary work. Briefly describe experience or preliminary work or data (if any) that you or your team have that supports the feasibility and/or safety of this study. Nine years of research and development to show that fetal EEG measurements can predict the level of acidemia at birth. Safety testing performed on site successfully for recording fetal EEG during labor as described.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Pregnant women of reproductive age in labor at term
Condition Pregnancy Abnormal
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 5, 2017)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Women in labor, with medical complications of pregnancy, such as IUGR, hypertension, diabetes, or obesity (BMI over 30).

Exclusion Criteria:

  1. Maternal or fetal infection or bleeding disorder;
  2. Birth through Caesarian section will only be excluded if decided a priori;
  3. Non-English speaking.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Martin G Frasch, MD, PhD 206-543-5892 mfrasch@uw.edu
Contact: Amy Gest, MPA 206-359-1961 agest@uw.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03013569
Other Study ID Numbers STUDY00003276
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Martin Frasch, University of Washington
Study Sponsor University of Washington
Collaborators Not Provided
Investigators
Principal Investigator: Martin G Frasch, MD, PhD University of Washington
PRS Account University of Washington
Verification Date September 2019