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.
Once in labor, the parturient will be connected to the routine fetal doppler and EUM. When necessary according to clinical indications, the scalp electrode will be connected. Tracing will be recorded simultaneously from all three devices until delivery.
Once in labor, the parturient will be connected to the routine fetal doppler and EUM. When
necessary according to clinical indications, the scalp electrode will be connected. Tracing
will be recorded simultaneously from all three devices until delivery.
study design:
1. signing an informed consent at vas<3
2. admittance to delivery room.
3. Verifying inclusion and exclusion criteria, describing clinical rial goal, motivation
and phases.
4. Connecting the patient to three devices (fetal Doppler, scalp electrode and EUM)
simultaneously.
5. Recording fetal heart rate until delivery.
6. Disconnecting the patient from all devices if required according to clinical need.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Diagnostic
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