Fetal Heartbeat TracingsPhase 3NCT02864225
To Compare the Efficacy Between 3 Fetal Monitoring Methods (EUM)
A Phase 3 study testing Scalp electrode,, Fetal doppler and EUM in people with Fetal Heartbeat Tracings, run by Tel-Aviv Sourasky Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Heartbeat Tracings
- What is being tested?
- Scalp electrode,, Fetal doppler and EUM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Sep 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Women who refused to sign the informed consent form.
- Maternal age < 18 years.
- Multiple pregnancy
- Woman with implanted electronic device of any kind
- Woman with allergic to silver.
- Irritated skin or open wound
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Fetal Heartbeat Tracings
- Being tested
- Scalp electrode,, Fetal doppler, EUM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scalp electrode,Device
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
Fetal dopplerDevice
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
EUMDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Scalp electrode, fetal doppler and EUM | Experimental | 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. Receives: Device: Scalp electrode,; Device: Fetal doppler; Device: EUM |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between the fetal scalp electrode tracings and the EUM tracings of the fetal heart activity.
Mean Positive Percent Agreement (PPA) for interpretable/un interpretable traces (between EUM, scalp electrode and fetal doppler).
Measured: Up to 72 hours
Reliability
Mean sensitivity for individual tracing identification (between EUM, scalp electrode and fetal doppler)
Measured: Up to 72 hours
Reliability
Mean Positive Predictive Value (PPV) for individual tracing identification (between EUM, scalp electrode and fetal doppler)
Measured: Up to 72 hours
Reliability
The mean False Positive Rate (FPR) for individual tracing identification (between EUM, scalp electrode and fetal Doppler)
Measured: Up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Heartbeat TracingsStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yariv Yogev, professor, Study chair, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864225
- Sponsor's protocol ID
- 573-15-TLV
- Status last verified
- Aug 2016
- First submitted
- 8 Aug 2016
- Last updated
- 15 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02864225
- Acronym / sponsor ID
- 573-15-TLV
- Conditions
- Fetal Heartbeat Tracings
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Sep 2016
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scalp electrode, fetal doppler and EUM | Experimental | Device: Scalp electrode,, Device: Fetal doppler, Device: EUMOnce 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- Women who refused to sign the informed consent form.
- Maternal age < 18 years.
- Multiple pregnancy
- Woman with implanted electronic device of any kind
- Woman with allergic to silver.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scalp electrode,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 | Device | Scalp electrode, fetal doppler and EUM |
| Fetal dopplerthe 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 | Device | Scalp electrode, fetal doppler and EUM |
| EUMthe 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 | Device | Scalp electrode, fetal doppler and EUM |
Primary outcome
The difference between the fetal scalp electrode tracings and the EUM tracings of the fetal heart activity.
Time frame: Up to 72 hours
Mean Positive Percent Agreement (PPA) for interpretable/un interpretable traces (between EUM, scalp electrode and fetal doppler).
Reliability
Time frame: Up to 72 hours
Mean sensitivity for individual tracing identification (between EUM, scalp electrode and fetal doppler)
Reliability
Time frame: Up to 72 hours
Mean Positive Predictive Value (PPV) for individual tracing identification (between EUM, scalp electrode and fetal doppler)
Reliability
Time frame: Up to 72 hours
The mean False Positive Rate (FPR) for individual tracing identification (between EUM, scalp electrode and fetal Doppler)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2016.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yariv Yogev, professor study chair
Tel Aviv Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Scalp electrode,, Fetal doppler and EUM in people with Fetal Heartbeat Tracings, run by Tel-Aviv Sourasky Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yariv Yogev, professor (052-7360616, yarivy@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference between the fetal scalp electrode tracings and the EUM tracings of the fetal heart activity. (time frame: Up to 72 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2016.