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
|Condition or disease|
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|
|Estimated Enrollment :||30 participants|
|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|
- 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
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
|Contact: Martin G Frasch, MD, PhDfirstname.lastname@example.org|
|Contact: Amy Gest, MPAemail@example.com|
|United States, Washington|
|University of Washington||Recruiting|
|Seattle, Washington, United States, 98195|
|Contact: Martin G Frasch, MD, PhD 206-543-5892 firstname.lastname@example.org|
|Contact: Amy Gest, MPA 206-359-1961 email@example.com|
|Principal Investigator:||Martin G Frasch, MD, PhD||University of Washington|