Spontaneous Fetal EEG Recording During Labor

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.

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.