To Compare the Efficacy Between 3 Fetal Monitoring Methods

NCT02331888 | Unknown Phase 3 DMC

• 1 other identifier: 0131-14-RMC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fetal Heartbeat Tracings

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Reliability

  12 months

• Reliability

  12 months

• Reliability

  12 months

• Accuracy

  12 months

• Accuracy

  12 months

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, fetal doppler and EUM

Interventions

Scalp electrode, fetal doppler and 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 - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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 (Biophysical Profile) 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 singed and dated the written informed consent form before initiation of protocol specified procedures, when vas\<3.

You may not qualify if:

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

Sponsors & Collaborators

• Yariv yogev: lead
• OB-Tools Ltd.: collaborator

Study Sites (1)

Rabin Medical Center

Petah Tikva, Israel, Israel

RECRUITING

Study Officials

• Yariv Yogev, professor

  Director, division of obstetrics and delivery ward Rabin medical center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yariv Yogev, professor

CONTACT

972-3-9377494; yarivy@clalit.org.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
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Yariv Yogev Director, Division of Obstetrics and Delivery Ward

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: January 6, 2015
• Study Start: May 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 9, 2015

Record last verified: 2015-09

Locations

IL (1)