To Compare the Efficacy Between 3 Fetal Monitoring Methods

Phase 3

• Conditions: Fetal Heartbeat Tracings
• Interventions: Device: Scalp electrode, fetal doppler and EUM

• Registration Number: NCT02331888
• Lead Sponsor: Yariv yogev

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.

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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-12-11
• Study First Submitted QC: 2015-01-04
• Study First Posted: 2015-01-06
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-07
• Last Update Posted: 2015-09-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Exclusion Criteria

1. Women who refuse to sign the informed consent form.
2. Maternal age<18 years.
3. Multiple pregnancy.
4. Women with implanted electronic device of any kind.
5. Women with allergic to silver.
6. Irritated skin or open wound.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Scalp electrode, fetal doppler and EUM	Scalp electrode, fetal doppler and EUM	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.

Primary Outcome Measures

Name	Time	Method
The difference between the fetal scalp electrode tracings and the EUM tracings of the fetal heart activity.	12 month	Mean Positive Percent Agreement (PPA) for interpretable/un interpretable traces (between EUM, scalp electrode and fetal doppler).

Secondary Outcome Measures

Name	Time	Method
Reliability	12 months	The mean False Positive Rate (FPR) for individual tracing identification (between EUM, scalp electrode and fetal Doppler)
Accuracy	12 months	The difference in periodic changes (between EUM, scalp electrode and fetal Doppler).
Adverse events	12 months	Number and percentage of adverse events during the study period

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petah tikva, Israel