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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

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.

Condition or disease
Pregnancy Abnormal

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.


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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Can Spontaneous Fetal EEG Be Recorded During Labor Using the Established Fetal Scalp Electrode Heart Rate Monitoring System?
Study Start Date : January 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pregnant women of reproductive age in labor at term
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.

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): NCT03013569


Contacts
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Contact: Martin G Frasch, MD, PhD 206-543-5892 mfrasch@uw.edu
Contact: Amy Gest, MPA 206-359-1961 agest@uw.edu

Locations
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United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Martin G Frasch, MD, PhD    206-543-5892    mfrasch@uw.edu   
Contact: Amy Gest, MPA    206-359-1961    agest@uw.edu   
Sponsors and Collaborators
University of Washington
Investigators
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Principal Investigator: Martin G Frasch, MD, PhD University of Washington

Additional Information:
Publications:
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Responsible Party: Martin Frasch, Research Assistant Professor, Obstetrics and Gynecology, University of Washington
ClinicalTrials.gov Identifier: NCT03013569     History of Changes
Other Study ID Numbers: STUDY00003276
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 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