Spontaneous Fetal EEG Recording During Labor
Condition: Pregnancy Abnormal
Study type: Observational

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.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant women of reproductive age in labor at term