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

Summary

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.

Conditions

• Fetal Heartbeat Tracings

Interventions

DEVICE

Scalp electrode,

the parturient will be connected to the routine fetal Doppler and to the EUM. and When necessary to the scalp electrode will be connected. Tracings will be recorded simultaneously from all three devices until delivery. three separate outputs will be processed Output of the scalp electrode recording. Output of the fetal doppler. Output of the EUM. Three noncontinuous segments of 30 minutes each with two segments occurring during the first stage of labor and the third occurring during the second stage of labor, will be randomly picked from the scalp electrode recording with 3 matching segments in time from the EUM100pro and the fetal doppler

DEVICE

Fetal doppler

the parturient will be connected to the routine fetal Doppler and to the EUM. and When necessary to the scalp electrode will be connected. Tracings will be recorded simultaneously from all three devices until delivery. three separate outputs will be processed Output of the scalp electrode recording. Output of the fetal doppler. Output of the EUM. Three noncontinuous segments of 30 minutes each with two segments occurring during the first stage of labor and the third occurring during the second stage of labor, will be randomly picked from the scalp electrode recording with 3 matching segments in time from the EUM100pro and the fetal doppler

DEVICE

EUM

the parturient will be connected to the routine fetal Doppler and to the EUM. and When necessary to the scalp electrode will be connected. Tracings will be recorded simultaneously from all three devices until delivery. three separate outputs will be processed Output of the scalp electrode recording. Output of the fetal doppler. Output of the EUM. Three noncontinuous segments of 30 minutes each with two segments occurring during the first stage of labor and the third occurring during the second stage of labor, will be randomly picked from the scalp electrode recording with 3 matching segments in time from the EUM100pro and the fetal doppler

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center

  lead OTHER_GOV

Principal Investigators

• Yariv Yogev, professor · Tel Aviv Medical Center

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

DOUBLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-09-30

Primary Completion

2019-09-30

Completion

2019-09-30