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

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.

Study Overview

• Status: Unknown
• Conditions: Fetal Heartbeat Tracings
• Intervention / Treatment: Device: Scalp electrode,; Device: Fetal doppler; Device: EUM

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 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 signed and dated, the written informed consent form before initiation of protocol-specified procedures, when VAS <3.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Scalp electrode, fetal doppler and EUM; 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference between the fetal scalp electrode tracings and the EUM tracings of the fetal heart activity.	Mean Positive Percent Agreement (PPA) for interpretable/un interpretable traces (between EUM, scalp electrode and fetal doppler).	Up to 72 hours
Reliability	Mean sensitivity for individual tracing identification (between EUM, scalp electrode and fetal doppler)	Up to 72 hours
Reliability	Mean Positive Predictive Value (PPV) for individual tracing identification (between EUM, scalp electrode and fetal doppler)	Up to 72 hours
Reliability	The mean False Positive Rate (FPR) for individual tracing identification (between EUM, scalp electrode and fetal Doppler)	Up to 72 hours

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Investigators: Study Chair: Yariv Yogev, professor, Tel Aviv Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: August 8, 2016
• First Submitted That Met QC Criteria: August 10, 2016
• First Posted (Estimate): August 11, 2016

Study Record Updates

• Last Update Posted (Estimate): August 15, 2016
• Last Update Submitted That Met QC Criteria: August 11, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 573-15-TLV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No