PregnancyNCT01681498
Fetal Electrocardiogram Extraction-Pilot Study
An observational study of Pregnancy, run by Huntleigh Healthcare Ltd at 1 site in United States.
Trial summary
This is a pilot study utilizing trans-abdominal ECG and Doppler Ultrasounds to assess the feasibility of extracting fECGs in a volunteer population. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to May 2015
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Prenatal care clinic
Who may be able to join
- Subjects must be pregnant women at least 18 years of age.
- Subject's fetus must be between the gestational ages of 16 weeks and term.
- Subjects must be able to tolerate 20 minutes (per fetus for which trans-abdominal ECG and Doppler ultrasounds will be performed) in the supine position.
- Subjects are willing to provide informed consent and are willing to participate in all procedures necessary to complete the study.
Who cannot join
- Subjects must not have a physical or mental condition, in the opinion of the investigator, which will limit their ability to provide adequate consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wheaton Franciscan, Inc. - St. Joseph
Milwaukee, Wisconsin, 53210
About this study
This is a pilot study utilizing trans-abdominal ECG and Doppler Ultrasounds to assess the feasibility of extracting fECGs in a volunteer population.
- Conditions
- Pregnancy
- Keywords
- pregnant, fetal ecg, ecg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnancy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beat-to-beat fetal heart rate will be compared to the Doppler result.
Beat-to-beat fetal heart rate will be compared to the Doppler result using Pearson Correlation. Timing of PR, QT, and QS, if visible, will be compared with published normative values from the neonatology literature as these values are not otherwise obtainable in an ongoing pregnancy.
Measured: 2 years
Secondary outcomes (1)
Evaluate the presence of other fECG intervals.
The fECG Separation Algorithm used in this research incorporates the filtering of noise of very high level as compared with the signal to be retrieved , in combination with employment of SVD (Singular Value Decomposition) methods.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study startMay 2013
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Why it stopped: Indeterminate performance during the first half of the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huntleigh Healthcare Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Menachem H. Graupe, MD, Principal investigator, Wheaton Franciscan Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681498
- Sponsor's protocol ID
- 12-010
- Status last verified
- Sep 2014
- First submitted
- 30 Aug 2012
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Electrocardiogram Extraction-Pilot Study
- ClinicalTrials.gov ID
- NCT01681498
- Acronym / sponsor ID
- 12-010
- Conditions
- Pregnancy
- Keywords
- pregnant, fetal ecg, ecg
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Indeterminate performance during the first half of the trial.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Huntleigh Healthcare LtdIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 10 Sep 2012 (estimated)
- 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.
This is a pilot study utilizing trans-abdominal ECG and Doppler Ultrasounds to assess the feasibility of extracting fECGs in a volunteer population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnancy | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Prenatal care clinic
Key inclusion criteria (4 listed)
- Subjects must be pregnant women at least 18 years of age.
- Subject's fetus must be between the gestational ages of 16 weeks and term.
- Subjects must be able to tolerate 20 minutes (per fetus for which trans-abdominal ECG and Doppler ultrasounds will be performed) in the supine position.
- Subjects are willing to provide informed consent and are willing to participate in all procedures necessary to complete the study.
Key exclusion criteria (1 listed)
- Subjects must not have a physical or mental condition, in the opinion of the investigator, which will limit their ability to provide adequate consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Beat-to-beat fetal heart rate will be compared to the Doppler result.
Time frame: 2 years
Beat-to-beat fetal heart rate will be compared to the Doppler result using Pearson Correlation. Timing of PR, QT, and QS, if visible, will be compared with published normative values from the neonatology literature as these values are not otherwise obtainable in an ongoing pregnancy.
1 secondary outcome
Evaluate the presence of other fECG intervals.
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Indeterminate performance during the first half of the trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2014.
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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.
Menachem H. Graupe, MD principal investigator
Wheaton Franciscan Healthcare
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 Pregnancy, run by Huntleigh Healthcare Ltd at 1 site in United States.
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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 3 Sep 2014. 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 United States. 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 was stopped early (reason given: Indeterminate performance during the first half of the trial.). Results are not available in the source record.
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?
Beat-to-beat fetal heart rate will be compared to the Doppler result. (time frame: 2 years). 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 3 Sep 2014.