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

NCT02864225 | Unknown Phase 3 DMC

• 1 other identifier: 573-15-TLV
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Scalp electrode, fetal doppler and EUM

EXPERIMENTAL

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,; Device: Fetal doppler; Device: EUM

Interventions

Scalp electrode, DEVICE

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

Scalp electrode, fetal doppler and EUM

Fetal doppler DEVICE

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

Scalp electrode, fetal doppler and EUM

EUM DEVICE

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

Scalp electrode, fetal doppler and EUM

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical indication to insert a scalp electrode for fetal heart rate tracing.
• Maternal age \>18 years
• Reactive fetal heart rate monitoring and BPP 8/8 at enrollment
• Singleton pregnancy
• No fetal abnormality or chromosomal defect
• Subjects are willing and able to comply with the requirements of the protocol.
• Fully understand all elements of, and have signed and dated, the written informed consent form before initiation of protocol-specified procedures, when VAS \<3.

You may not qualify if:

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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Officials

• Yariv Yogev, professor

  Tel Aviv Medical Center

  STUDY CHAIR

Central Study Contacts

Yariv Yogev, professor

CONTACT

052-7360616; yarivy@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 11, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: August 15, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share