NCT02331888

To Compare the Efficacy Between 3 Fetal Monitoring Methods

A Prospective, Blinded Clinical Study to Compare the Efficacy Between Three Fetal Monitoring Methods: Electro Uterine Monitor (EUM), Fetal Doppler and Scalp Electrode.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Yariv yogev · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Fetal Heartbeat Tracings

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2015-01-06
• Last updated: 2015-09-09

Locations

1 site across 1 country: Israel