Fetal Heartbeat Tracings
Conditions
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.
Interventions
DEVICEScalp 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.
Sponsors
OB-Tools Ltd.
Yariv yogev
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Reliability | 12 months | Mean sensitivity for individual tracing identification (between EUM, scalp electrode and fetal doppler) |
| Accuracy | 12 months | The difference in fetal heart rate baseline and variability (between EUM, scalp electrode and fetal doppler) |
| Adverse events | 12 months | Number and percentage of adverse events during the study period |
Countries
Israel
Contacts
Primary ContactYariv Yogev, professor
Outcome results
None listed