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A Home Telemonitoring System for Wearable Fetal-ECG and EHG Acquisition During Pregnancy (AHTSWFEADP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06031142
Recruitment Status : Completed
First Posted : September 11, 2023
Last Update Posted : September 11, 2023
Sponsor:
Information provided by (Responsible Party):
Hao Li, Fudan University

Tracking Information
First Submitted Date August 29, 2023
First Posted Date September 11, 2023
Last Update Posted Date September 11, 2023
Actual Study Start Date May 29, 2023
Actual Primary Completion Date July 29, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 3, 2023)
  • The performance of this system in extracting fetal electrocardiogram (FECG) [ Time Frame: 2022.01-2023.08 ]
    extract fetal QRS intervals and numbers from FECG
  • The performance of this system in extracting electrohysterography (EHG) [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Home Telemonitoring System for Wearable Fetal-ECG and EHG Acquisition During Pregnancy
Official Title Flexible Wearable Device for Continuous Fetal Heart Rate and Movement Monitoring.
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Family-Based
Time Perspective: Prospective
Target Follow-Up Duration 4 Weeks
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population A wearable and remote fetal monitoring system is specifically developed for home use. It aims to overcome the limitations of conventional cardiotocography (CTG) devices by providing great user comfort and long-term continuous monitoring.
Condition
  • Uterine Contractions; Prolonged
  • Fetal Heart Rate or Rhythm Abnormality Affecting Fetus
  • Pregnancy Related
  • Home Range
Intervention Device: use wearable devices to monitoring fetal health conditions.
We used wearable devices and clinical cardiotocography (CTG) equipment to monitor pregnant women for 30 minutes to demonstrate the reliability of wearable devices.
Other Names:
  • Non-invasive monitoring
  • FECG
  • EHG
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 3, 2023)		 4
Original Actual Enrollment Same as current
Actual Study Completion Date August 6, 2023
Actual Primary Completion Date July 29, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT06031142
Other Study ID Numbers PROFE23186I
2022YFB4400800 ( Other Grant/Funding Number: the National Key R&D Program of China )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Hao Li, Fudan University
Original Responsible Party Same as current
Current Study Sponsor Fudan University
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Tingting Li, master Fudan University
PRS Account Fudan University
Verification Date September 2023