To Compare the Efficacy Between 3 Fetal Monitoring Methods (NCT02331888) | Clinical Trial Compass
UnknownPhase 3
To Compare the Efficacy Between 3 Fetal Monitoring Methods
Israel100 participantsStarted 2014-05
Plain-language 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.
Who can participate
Age range
18 Years – 45 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 (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.
Exclusion criteria
. Women who refuse to sign the informed consent form.
. Maternal age\<18 years.
. Multiple pregnancy.
. Women with implanted electronic device of any kind.
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
1
The difference between the fetal scalp electrode tracings and the EUM tracings of the fetal heart activity.