Fetal Heartbeat Tracings Clinical Trial
Official title:
A Prospective, Blinded Clinical Study to Compare the Efficacy Between Three Fetal Monitoring Methods: Electro Uterine Monitor (EUM), Fetal Doppler and Scalp Electrode
Background:
Identification and measurement of fetal heart tracings throughout pregnancy and labor is
crucial to the well-being of the fetus. Non reassuring fetal heart rate is one of the most
common indications for operative vaginal delivery or cesarean section. Therefore, management
of labor requires reliable and accurate information about fetal heart rate.
In most normal spontaneous labors, fetal heart rate is characterized by the baseline heart
rate (from 110 to 160 beats per minute), variability (beat to beat changes) and periodic
changes (accelerations or decelerations). In each stage of labor the tracing may have
different characteristics, with variable decelerations much more common at the end of the
second stage of labor.
Objective:
To Show non inferiority of the EUM to the fetal doppler and scalp electrode by comparing the
reliability and accuracy of the EUM versus fetal doppler compared to scalp electrode in the
same patients.
Background:
Identification and measurement of fetal heart tracings throughout pregnancy and labor is
crucial to the well-being of the fetus. Non reassuring fetal heart rate is one of the most
common indications for operative vaginal delivery or cesarean section. Therefore, management
of labor requires reliable and accurate information about fetal heart rate.
In most normal spontaneous labors, fetal heart rate is characterized by the baseline heart
rate (from 110 to 160 beats per minute), variability (beat to beat changes) and periodic
changes (accelerations or decelerations). In each stage of labor the tracing may have
different characteristics, with variable decelerations much more common at the end of the
second stage of labor.
Objective:
To Show non inferiority of the EUM to the fetal doppler and scalp electrode by comparing the
reliability and accuracy of the EUM versus fetal doppler compared to scalp electrode in the
same patients.
METHODS The current method for detecting fetal heart rate is fetal Doppler, which is
routinely used in practically all labors, is based on the Doppler technology of detecting
heart valves motion and blood velocity. The fetal Doppler transducer is placed on the
abdomen of the parturient and is susceptible to positional changes of the parturient.
Moreover, among obese gravidas, fetal heart rate tracings via external fetal Doppler may be
difficult to achieve.
Another method for monitoring fetal heart rate is the scalp electrode which is attached to
the fetal scalp and records the heart rate patterns. This method is invasive and can be used
only after the amniotic membranes are ruptured.
Monitoring with scalp electrode is superior to the fetal Doppler as it is direct and
non-affected by maternal position. However, it is an invasive method and may contribute to
the development fever during or after labor.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Diagnostic
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
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Phase 3 | |
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