A Home Telemonitoring System for Wearable Fetal-ECG and EHG Acquisition During Pregnancy (NCT06031142) | Clinical Trial Compass
CompletedNot Applicable
A Home Telemonitoring System for Wearable Fetal-ECG and EHG Acquisition During Pregnancy
China4 participantsStarted 2023-05-29
Plain-language summary
The goal of this observational is to compare in describing fetal health conditions. The main questions it aims to answer are:
* fetal electrocardiogram (fetal heart rate and fetal rhythm)
* electrohysterography (uterine contractions).
Participants will wear wearable devices and CTG equipment for monitoring for 30 minutes.If there is a comparison group: Researchers will compare clinical CTG equipment to see if this wearable device.
Who can participate
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:
* Pregnant women with a gestational cycle greater than 36 weeks
Exclusion Criteria:
* male
* Pregnant women with a gestational cycle less than 36 weeks
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.
1This trial used a wearable home device to monitor fetal heart rhythms and uterine contractions during pregnancy — given my specific situation, could you review the results of this completed study and tell me whether the technology performed well enough to be relevant to my care?
2Since this trial focused on extracting fetal ECG and electrohysterography signals at home rather than in a clinical setting, how does the quality of monitoring from a wearable home system compare to what you'd get from the equipment used in your office or the hospital?
3The trial was tracking uterine contractions and fetal heart rate or rhythm abnormalities — based on my pregnancy, do you think home telemonitoring of these specific signals would add useful information to my care, or would standard in-clinic monitoring be more appropriate for me?
4Because this was a non-drug, device-focused study rated as 'Phase NA,' what do we know about the reliability and any limitations of this kind of wearable technology before it might be used in routine pregnancy monitoring?
5If home fetal ECG and uterine monitoring becomes available based on studies like this one, what would that actually mean for my appointments and daily routine — would it reduce how often I need to come in, or would it be used alongside regular visits?
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 performance of this system in extracting fetal electrocardiogram (FECG)
Timeframe: 2022.01-2023.08
2
The performance of this system in extracting electrohysterography (EHG)