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 range

18 Years

Sex

FEMALE

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The difference between the fetal scalp electrode tracings and the EUM tracings of the fetal heart activity.

Timeframe: Up to 72 hours

Reliability

Timeframe: Up to 72 hours

Reliability

Timeframe: Up to 72 hours

Reliability

Timeframe: Up to 72 hours

Trial details

NCT IDNCT02864225

SponsorTel-Aviv Sourasky Medical Center

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2019-09

Contact for this trial

Yariv Yogev, professor

052-7360616 yarivy@tlvmc.gov.il

View on ClinicalTrials.gov More Fetal Heartbeat Tracings trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

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.