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.

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 Overview

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

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yariv Yogev, professor; Phone Number: 972-3-9377494; Email: yarivy@clalit.org.il

Study Locations

• Israel
  • Petah tikva, Israel
    • Recruiting
    • Rabin Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• 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 (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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• 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, fetal doppler and 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).	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reliability	Mean sensitivity for individual tracing identification (between EUM, scalp electrode and fetal doppler)	12 months
Reliability	Mean Positive Predictive Value (PPV) for individual tracing identification (between EUM, scalp electrode and fetal doppler)	12 months
Reliability	The mean False Positive Rate (FPR) for individual tracing identification (between EUM, scalp electrode and fetal Doppler)	12 months
Accuracy	The difference in fetal heart rate baseline and variability (between EUM, scalp electrode and fetal doppler)	12 months
Accuracy	The difference in periodic changes (between EUM, scalp electrode and fetal Doppler).	12 months
Adverse events	Number and percentage of adverse events during the study period	12 months

Collaborators and Investigators

• Sponsor: Yariv yogev
• Collaborators: OB-Tools Ltd.
• Investigators: Principal Investigator: Yariv Yogev, professor, Director, division of obstetrics and delivery ward Rabin medical center

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (ANTICIPATED): September 1, 2015
• Study Completion (ANTICIPATED): September 1, 2015

Study Registration Dates

• First Submitted: December 11, 2014
• First Submitted That Met QC Criteria: January 4, 2015
• First Posted (ESTIMATE): January 6, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): September 9, 2015
• Last Update Submitted That Met QC Criteria: September 7, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 0131-14-RMC