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

Fetal Heartbeat Tracings Clinical Trial

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: Not yet recruiting

Administrative data

• NCT number: NCT02864225
• Other study ID #: 573-15-TLV
• Status: Not yet recruiting
• Phase: Phase 3
• First received: August 8, 2016
• Last updated: August 11, 2016
• Start date: September 2016
• Est. completion date: September 2019

Study information

• Verified date: August 2016
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Yariv Yogev, professor
• Phone: 052-7360616
• Email: yarivy[@]tlvmc.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

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 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 Design

Endpoint Classification: 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,
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
• 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
• 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
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

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).	Up to 72 hours	No
Primary	Reliability	Mean sensitivity for individual tracing identification (between EUM, scalp electrode and fetal doppler)	Up to 72 hours	No
Primary	Reliability	Mean Positive Predictive Value (PPV) for individual tracing identification (between EUM, scalp electrode and fetal doppler)	Up to 72 hours	No
Primary	Reliability	The mean False Positive Rate (FPR) for individual tracing identification (between EUM, scalp electrode and fetal Doppler)	Up to 72 hours	No