Uterine Contractions; ProlongedAHTSWFEADPNCT06031142
A Home Telemonitoring System for Wearable Fetal-ECG and EHG Acquisition During Pregnancy
An observational study of Uterine Contractions; Prolonged and Fetal Heart Rate or Rhythm Abnormality Affecting Fetus, run by Fudan University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Contractions; Prolonged, Fetal Heart Rate or Rhythm Abnormality Affecting Fetus, Pregnancy Related
- What is being tested?
- use wearable devices to monitoring fetal health conditions.
- Type of treatment
- Medical device
- How many people
- 4 participants
- Where
- 1 siteChina
- Study dates
- 29 May 2023to 6 Aug 2023
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Pregnant women with a gestational cycle greater than 36 weeks
Who cannot join
- male
- Pregnant women with a gestational cycle less than 36 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Flexible Wearable Device for Continuous Fetal Heart Rate and Movement Monitoring.
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.
Read the 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.
- Conditions
- Uterine Contractions; Prolonged, Fetal Heart Rate or Rhythm Abnormality Affecting Fetus, Pregnancy Related, Home Range
- Being tested
- use wearable devices to monitoring fetal health conditions.
- Keywords
- FECG, EHG
- Medical subject headings
- Homing Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use wearable devices to monitoring fetal health conditions.Device
Also called Non-invasive monitoring, FECG, EHG
We used wearable devices and clinical cardiotocography (CTG) equipment to monitor pregnant women for 30 minutes to demonstrate the reliability of wearable devices.
What is being measured
The primary outcome is the main question the study is designed to answer.
The performance of this system in extracting fetal electrocardiogram (FECG)
extract fetal QRS intervals and numbers from FECG
Measured: 2022.01-2023.08
The performance of this system in extracting electrohysterography (EHG)
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.
Measured: 2022.01-2023.08
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start29 May 2023
- Primary completion29 Jul 2023
- Study completion6 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Contractions; ProlongedStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Li, Fudan University
- Investigators
- Tingting Li, master, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031142
- Sponsor's protocol ID
- PROFE23186I
- Other IDs
- 2022YFB4400800
- Acronym
- AHTSWFEADP
- Status last verified
- Sep 2023
- First submitted
- 29 Aug 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flexible Wearable Device for Continuous Fetal Heart Rate and Movement Monitoring.
- ClinicalTrials.gov ID
- NCT06031142
- Acronym / sponsor ID
- AHTSWFEADP / PROFE23186I
- Conditions
- Uterine Contractions; Prolonged, Fetal Heart Rate or Rhythm Abnormality Affecting Fetus, Pregnancy Related, Home Range
- Keywords
- FECG, EHG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 29 May 2023 (actual)
- Primary completion
- 29 Jul 2023 (actual)
- Study completion
- 6 Aug 2023 (actual)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Family based
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Pregnant women with a gestational cycle greater than 36 weeks
Key exclusion criteria (2 listed)
- male
- Pregnant women with a gestational cycle less than 36 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| use wearable devices to monitoring fetal health conditions.Also: Non-invasive monitoring, FECG, EHGWe used wearable devices and clinical cardiotocography (CTG) equipment to monitor pregnant women for 30 minutes to demonstrate the reliability of wearable devices. | Device | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tingting Li, master principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Contractions; Prolonged and Fetal Heart Rate or Rhythm Abnormality Affecting Fetus, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The performance of this system in extracting fetal electrocardiogram (FECG) (time frame: 2022.01-2023.08). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.