To Compare the Efficacy Between 3 Fetal Monitoring Methods (EUM)

Yariv yogev

Status and phase: Unknown; Phase 3

Conditions: Fetal Heartbeat Tracings

Treatments: Device: Scalp electrode, fetal doppler and EUM

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02331888

0131-14-RMC

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Clinical indication to insert a scalp electrode for fetal heart rate tracing.
2. Maternal age>18 years.
3. Reactive fetal heart rate monitoring and BPP (Biophysical Profile) 8/8 at enrollment.
4. Singleton pregnancy.
5. No fetal abnormality or chromosomal defect.
6. Subjects are willing and able to comply with the requirements of the protocol.
7. Fully understand all elements of, and have singed and dated the written informed consent form before initiation of protocol specified procedures, when vas<3.

Exclusion criteria

1. Women who refuse to sign the informed consent form.
2. Maternal age<18 years.
3. Multiple pregnancy.
4. Women with implanted electronic device of any kind.
5. Women with allergic to silver.
6. Irritated skin or open wound.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

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100 participants in 1 patient group

Scalp electrode, fetal doppler and EUM

Experimental group

Description:

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.

Treatment:

Device: Scalp electrode, fetal doppler and EUM