Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT03930277 |
| Other study ID # |
0354-18-RMB |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 31, 2022 |
| Est. completion date |
March 1, 2024 |
Study information
| Verified date |
April 2022 |
| Source |
Rambam Health Care Campus |
| Contact |
Roy Lauterbach, MD |
| Phone |
972-52-9432416 |
| Email |
r_lauterbach[@]rambam.health.gov.il |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Fetal cardiac monitoring is used during labor. Fetal decelerations may imply fetal hypoxia
and distress. Brain activity monitoring is not used to evaluate fetal distress during labor.
In this study the investigators intend to use an EEG based algorithm to evaluate and monitor
fetal brain activity during the 2nd stage of labor.
Description:
Fetal heart rate (FHR) monitoring is commonly used in order to reduce fetal intrapartum
asphyxia or any associated long-term disabilities. The electronic fetal monitoring (EFM) was
first described by Hon and others during the 1960s (1) (2) and introduced into clinical
practice before any clear evidence of benefits had been demonstrated.
The EFM records the fetal heart rate, and characteristics such as baseline, accelerations,
decelerations and variability are constantly evaluated in order to assess the hypoxic
condition of the fetus and to identify fetal distress.
Nevertheless, most of the studies (3-5) demonstrated that abnormal patterns of the fetal
heart rate are of low predictive value for intrapartum fetal hypoxia or metabolic acidosis.
Among high-risk pregnant woman, the probability of fetal metabolic acidosis in the presence
of repeated, variable decelerations is 25%, and 48% in the presence of late decelerations
(6). According to the Cochrane review (7) EFM didn't decrease the rates of cerebral palsy
(CP), asphyxias complications or perinatal morbidity. The positive predictive value of
non-reassuring FHR patterns for the prediction of CP among singleton newborns with birth
weight of 2500 grams or more is only 0.14% (8).
Hypoperfusion to a certain brain areas involves the rapid loss of brain function due to
disturbances in brain blood supply. EEG shows typical changes in brain ischemia. These
changes include: attenuation of faster waves, particularly in the beta and alpha frequency
bands; enhancement of slower waves, mainly in the delta frequency band; regional attenuation
without delta enhancement (RAWOD) and reduction of variability in the EEG signal (9).
However, reaching effective sensitivity and specificity in immediate brain ischemia detection
on the basis of EEG changes is still considered a challenge, as it depends on the presence of
a skilled expert in neurophysiology to analyses raw EEG data in real-time.
The investigators developed a unique platform algorithm, which analyses EEG data, and
recognizes patients suffering from brain ischemia (stroke), based on the phenomena of
interhemispheric decreased synchronization. Interhemispheric synchronization is the measure
of correlation in EEG activity between ipsilateral and contralateral hemispheres, where
values range between 1 (complete synchronization) and 0 (no synchronization). Increased
synchronization means greater correlation between related ipsilateral and contralateral
activities and vice versa for decreased synchronization. Normal brains should have a high
correlation/ synchronization. Once brain ischemia occurs and the hemisphere is damaged, the
interhemispheric synchronization decreases. In a recent study, we have shown the decrease in
synchronization when a certain part of the brain is anaesthetized, causing a lesion similar
to brain ischemia, and the recovery of synchronization, when the anesthesia recovered2. In
another study, the investigators have tested the reliability of the algorithm in patients
undergoing mechanical thrombectomy for acute stroke. In the study patients with acute stroke
admitted to neuro angio intervention undergone short EEG test for 5 minutes. At the end of
the procedure patients underwent a second short EEG test. In the test the interhemispheric
synchronization were analyzed. It was shown that patients admitted to the neuro-angio
intervention, who had brain tissue that might be salvable, had an average synchronization of
0.8. If the procedure succeeded and there was a clinical improvement - the synchronization
remained high. If the procedure did not succeed, or succeed without clinical improvement, the
synchronization decreased to an average of 0.65. Importantly, patients who were not
candidates for neuro intervention, because they didn't have salvable brain, their index of
synchronization was low to begin with (figure 1a and 1b). This preliminary assay proves the
ability of the synchronization index to detect brain hypoperfusion that occurs, for example,
in stroke.
The objective of this proof of concept study is to test whether there is a correlation
between the EEG index of interhemispheric synchronization, to the umbilical PH of the newborn
and to the gold standard fetal heart rate monitor.
