To Compare the Efficacy Between 3 Fetal Monitoring Methods (EUM) (NCT02864225) | Clinical Trial Compass
UnknownPhase 3
To Compare the Efficacy Between 3 Fetal Monitoring Methods (EUM)
400 participantsStarted 2016-09
Plain-language summary
Background:
Identification and measurement of fetal heart tracings throughout pregnancy and labor is crucial to the well-being of the fetus. Non reassuring fetal heart rate is one of the most common indications for operative vaginal delivery or cesarean section. Therefore, management of labor requires reliable and accurate information about fetal heart rate.
In most normal spontaneous labors, fetal heart rate is characterized by the baseline heart rate (from 110 to 160 beats per minute), variability (beat to beat changes) and periodic changes (accelerations or decelerations). In each stage of labor the tracing may have different characteristics, with variable decelerations much more common at the end of the second stage of labor.
Objective:
To Show non inferiority of the EUM to the fetal doppler and scalp electrode by comparing the reliability and accuracy of the EUM versus fetal doppler compared to scalp electrode in the same patients.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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 signed and dated, the written informed consent form before initiation of protocol-specified procedures, when VAS \<3.
Exclusion criteria
✕. Women who refused to sign the informed consent form.
✕. Maternal age \< 18 years.
✕. Multiple pregnancy
✕
What they're measuring
1
The difference between the fetal scalp electrode tracings and the EUM tracings of the fetal heart activity.