A Prospective, Blinded Clinical Study to Compare the Efficacy Between Three Fetal Monitoring Methods: Electro Uterine Monitor (EUM), Fetal Doppler and Scalp Electrode.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Fetal Heartbeat Tracings
- Sponsor
- Yariv yogev
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- The difference between the fetal scalp electrode tracings and the EUM tracings of the fetal heart activity.
- Last Updated
- 10 years ago
Overview
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.
Investigators
Yariv yogev
Prof. Yariv Yogev Director, Division of Obstetrics and Delivery Ward
Rabin Medical Center
Eligibility Criteria
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.
Outcomes
Primary Outcomes
The difference between the fetal scalp electrode tracings and the EUM tracings of the fetal heart activity.
Time Frame: 12 month
Mean Positive Percent Agreement (PPA) for interpretable/un interpretable traces (between EUM, scalp electrode and fetal doppler).
Secondary Outcomes
- Reliability(12 months)
- Accuracy(12 months)
- Adverse events(12 months)