Fetal Heartbeat TracingsPhase 3EUMNCT02331888
To Compare the Efficacy Between 3 Fetal Monitoring Methods
A Phase 3 study testing Scalp electrode, fetal doppler and EUM in people with Fetal Heartbeat Tracings, run by Yariv yogev at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, 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
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- May 2014to Sep 2015
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- 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 (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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center
Petah Tikva, Israel
Yariv Yogev, professor, yarivy@clalit.org.il
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.
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.
Read the 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:
- signing an informed consent at vas<3
- admittance to delivery room.
- Verifying inclusion and exclusion criteria, describing clinical rial goal, motivation and phases.
- Connecting the patient to three devices (fetal Doppler, scalp electrode and EUM) simultaneously.
- Recording fetal heart rate until delivery.
- Disconnecting the patient from all devices if required according to clinical need.
- Conditions
- Fetal Heartbeat Tracings
- Being tested
- Scalp electrode, fetal doppler and EUM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scalp electrode, fetal doppler and 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, fetal doppler and 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: 12 month
Secondary outcomes (6)
Reliability
Mean sensitivity for individual tracing identification (between EUM, scalp electrode and fetal doppler)
Measured: 12 months
Reliability
Mean Positive Predictive Value (PPV) for individual tracing identification (between EUM, scalp electrode and fetal doppler)
Measured: 12 months
Reliability
The mean False Positive Rate (FPR) for individual tracing identification (between EUM, scalp electrode and fetal Doppler)
Measured: 12 months
Accuracy
The difference in fetal heart rate baseline and variability (between EUM, scalp electrode and fetal doppler)
Measured: 12 months
Accuracy
The difference in periodic changes (between EUM, scalp electrode and fetal Doppler).
Measured: 12 months
Adverse events
Number and percentage of adverse events during the study period
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startMay 2014
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (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.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yariv yogev
- Sponsor type
- University, hospital or other
- Collaborators
- OB-Tools Ltd.
- Responsible party
- Sponsor-investigator, Yariv yogev, Rabin Medical Center
- Investigators
- Yariv Yogev, professor, Principal investigator, Director, division of obstetrics and delivery ward Rabin medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331888
- Sponsor's protocol ID
- 0131-14-RMC
- Acronym
- EUM
- Status last verified
- Sep 2015
- First submitted
- 11 Dec 2014
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. 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
- NCT02331888
- Acronym / sponsor ID
- EUM / 0131-14-RMC
- Conditions
- Fetal Heartbeat Tracings
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yariv yogevUniversity, hospital or other
- Collaborators
- OB-Tools Ltd.
- Study start
- May 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 6 Jan 2015 (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.
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:
- signing an informed consent at vas<3
- admittance to delivery room.
- Verifying inclusion and exclusion criteria, describing clinical rial goal, motivation and phases.
- Connecting the patient to three devices (fetal Doppler, scalp electrode and EUM) simultaneously.
- Recording fetal heart rate until delivery.
- Disconnecting the patient from all devices if required according to clinical need.
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, fetal doppler and 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 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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 (Biophysical Profile) 8/8 at enrollment.
- Singleton pregnancy.
- No fetal abnormality or chromosomal defect.
Key exclusion criteria (6 listed)
- 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.
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, fetal doppler and 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: 12 month
Mean Positive Percent Agreement (PPA) for interpretable/un interpretable traces (between EUM, scalp electrode and fetal doppler).
6 secondary outcomes
Reliability
Time frame: 12 months
Reliability
Time frame: 12 months
Reliability
Time frame: 12 months
Accuracy
Time frame: 12 months
Accuracy
Time frame: 12 months
Adverse events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
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 principal investigator
Director, division of obstetrics and delivery ward Rabin medical center
1 site in 1 country: see every site and its status.
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 Yariv yogev at 1 site in Israel.
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 9 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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 (972-3-9377494, yarivy@clalit.org.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: 12 month). 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 9 Sep 2015.