UnknownPhase 3

To Compare the Efficacy Between 3 Fetal Monitoring Methods

Israel100 participantsStarted 2014-05

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

The difference between the fetal scalp electrode tracings and the EUM tracings of the fetal heart activity.

Timeframe: 12 month

Trial details

NCT IDNCT02331888

SponsorYariv yogev

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-09

Contact for this trial

Yariv Yogev, professor

972-3-9377494 yarivy@clalit.org.il

View on ClinicalTrials.gov More Fetal Heartbeat Tracings trials