A Home Telemonitoring System for Wearable Fetal-ECG and EHG Acquisition During Pregnancy
- Conditions
- Pregnancy RelatedHome RangeUterine Contractions; ProlongedFetal Heart Rate or Rhythm Abnormality Affecting Fetus
- Registration Number
- NCT06031142
- Lead Sponsor
- Fudan University
- Brief 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.
- Detailed Description
The investigators put the patch of the wearable device on the abdomen of the pregnant woman and continued the test for thirty minutes.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 4
- Pregnant women with a gestational cycle greater than 36 weeks
- male
- Pregnant women with a gestational cycle less than 36 weeks
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The performance of this system in extracting fetal electrocardiogram (FECG) 2022.01-2023.08 extract fetal QRS intervals and numbers from FECG
The performance of this system in extracting electrohysterography (EHG) 2022.01-2023.08 use the contractions consistency index (CCI) parameters to analyze the relation between our measured EHG signal and the UC signal recorded by clinical CTG equipment.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
FetaCare
🇨🇳Shanghai, Pudong New District， Shanghai, China