To Compare the Efficacy Between 3 Fetal Monitoring Methods

Fetal Heartbeat Tracings Clinical Trial

— EUM  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02331888
• Other study ID #: 0131-14-RMC
• Status: Recruiting
• Phase: Phase 3
• First received: December 11, 2014
• Last updated: September 7, 2015
• Start date: May 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Rabin Medical Center
• Contact: Yariv Yogev, professor
• Phone: 972-3-9377494
• Email: yarivy[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Fetal Heartbeat Tracings

Intervention

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.

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petah tikva

Sponsors (2)

Lead Sponsor	Collaborator
Yariv yogev	OB-Tools Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Reliability	Mean sensitivity for individual tracing identification (between EUM, scalp electrode and fetal doppler)	12 months	No
Secondary	Reliability	Mean Positive Predictive Value (PPV) for individual tracing identification (between EUM, scalp electrode and fetal doppler)	12 months	No
Secondary	Reliability	The mean False Positive Rate (FPR) for individual tracing identification (between EUM, scalp electrode and fetal Doppler)	12 months	No
Secondary	Accuracy	The difference in fetal heart rate baseline and variability (between EUM, scalp electrode and fetal doppler)	12 months	No
Secondary	Accuracy	The difference in periodic changes (between EUM, scalp electrode and fetal Doppler).	12 months	No
Secondary	Adverse events	Number and percentage of adverse events during the study period	12 months	No