Clinical trial NCT02864225: To Compare the Efficacy Between 3 Fetal Monitoring Methods (EUM)
Official title: A Prospective, Blinded Clinical Study to Compare the Efficacy Between Three Fetal Monitoring Methods: Electro Uterine Monitor (EUM), Fetal Doppler and Scalp Electrode
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Fetal Heartbeat Tracings
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-08-11
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: 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.

METHODS The current method for detecting fetal heart rate is fetal Doppler, which is routinely used in practically all labors, is based on the Doppler technology of detecting heart valves motion and blood velocity. The fetal Doppler transducer is placed on the abdomen of the parturient and is susceptible to positional changes of the parturient. Moreover, among obese gravidas, fetal heart rate tracings via external fetal Doppler may be difficult to achieve.

Another method for monitoring fetal heart rate is the scalp electrode which is attached to the fetal scalp and records the heart rate patterns. This method is invasive and can be used only after the amniotic membranes are ruptured.

Monitoring with scalp electrode is superior to the fetal Doppler as it is direct and non-affected by maternal position. However, it is an invasive method and may contribute to the development fever during or after labor.

Eligibility criteria: 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 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 signed and dated, the written informed consent form before initiation of protocol-specified procedures, when VAS \<3.

Exclusion Criteria:

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

Primary outcomes:
measure: The difference between the fetal scalp electrode tracings and the EUM tracings of the fetal heart activity.
timeFrame: Up to 72 hours
measure: Reliability
timeFrame: Up to 72 hours
measure: Reliability
timeFrame: Up to 72 hours
measure: Reliability
timeFrame: Up to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tel Aviv Medical Center
name: Yariv Yogev, professor
role: STUDY_CHAIR
References: