Fetal Heart TracingNCT02546011
The Monica Fetal Heart Monitor
An observational study of Fetal Heart Tracing, run by St. Louis University at 1 site in United States.
Trial summary
The goal of this study is to compare the amount of time that the fetal heart tones are traced in babies just at or beyond viability using a traditional device compared to the Monica device. Read more about this study
- Who is it for?
- Ages 13 to 55 years, women only
- Conditions the study is for
- Fetal Heart Tracing
- What is being tested?
- Fetal Heart Rate Monitor
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jul 2016
- How long will I take part?
- 1 Week
- 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 13 to 55 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: The potential participants will be on the antepartum service so we will be providing them with antepartum and obstetrical care clinically.
Who may be able to join
- Pregnant patients between 24 and 28 weeks admitted to the antepartum service
Who cannot join
- Patients with a non viable pregnancy
- Patients with multiple gestation
- Clinically Unstable patients
- Non English speaking patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Monica External Fetal Heart Rate Monitor Compared to the Standard Fetal Heart Rate Monitor
The goal of this study is to compare the amount of time that the fetal heart tones are traced in babies just at or beyond viability using a traditional device compared to the Monica device.
Read the detailed description
If a patient is admitted to the antepartum service and is between 24 - 28 weeks gestation, the investigators will approach the patient and inform her about the study. If the patient agrees to the study then the baby's heart tracings and contraction pattern will start to be monitored using the traditional device. If the patient would be receiving continuous fetal heart rate monitoring, then after at least 2 hours of monitoring with the traditional device, the traditional device would be replaced with the Monica device for 2 hours. After the Monica device is used for 2 hours, then the traditional device would be used once again. The entire length of the patient's participation in the study should be nor more than 6 hours.
The data collection sheet shows all data elements to be collected from the medical record. In addition it is standard of care that the monitoring strips become part of the medical records and these will also be reviewed as per the data collection sheet. Time it should take to review a patients medical record will be about 1 hour.
Total time of patient's involvement will be 7 hours.
- Conditions
- Fetal Heart Tracing
- Being tested
- Fetal Heart Rate Monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal Heart Rate MonitorOther
Standard of care, not part of research
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the amount of time that the fetal heart tones are traced in babies just at or beyond viability using a traditional device compared to the Monica device
This study is to compare the amount of time that the fetal heart tones are traced in babies just at or beyond viability using a traditional device compared to the Monica device.
Measured: How long can hetal heart tracings be capture continuously
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startJan 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Heart TracingStudies 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
- 36 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, fruhman@slu.edu, St. Louis University
- Investigators
- Gary Fruhman, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546011
- Sponsor's protocol ID
- 24511
- Status last verified
- Aug 2016
- First submitted
- 8 Sep 2015
- Last updated
- 5 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Monica External Fetal Heart Rate Monitor Compared to the Standard Fetal Heart Rate Monitor
- ClinicalTrials.gov ID
- NCT02546011
- Acronym / sponsor ID
- 24511
- Conditions
- Fetal Heart Tracing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 10 Sep 2015 (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.
The goal of this study is to compare the amount of time that the fetal heart tones are traced in babies just at or beyond viability using a traditional device compared to the Monica device.
Detailed description
If a patient is admitted to the antepartum service and is between 24 - 28 weeks gestation, the investigators will approach the patient and inform her about the study. If the patient agrees to the study then the baby's heart tracings and contraction pattern will start to be monitored using the traditional device. If the patient would be receiving continuous fetal heart rate monitoring, then after at least 2 hours of monitoring with the traditional device, the traditional device would be replaced with the Monica device for 2 hours. After the Monica device is used for 2 hours, then the traditional device would be used once again. The entire length of the patient's participation in the study should be nor more than 6 hours.
The data collection sheet shows all data elements to be collected from the medical record. In addition it is standard of care that the monitoring strips become part of the medical records and these will also be reviewed as per the data collection sheet. Time it should take to review a patients medical record will be about 1 hour.
Total time of patient's involvement will be 7 hours.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 13 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The potential participants will be on the antepartum service so we will be providing them with antepartum and obstetrical care clinically.
Key inclusion criteria (1 listed)
- Pregnant patients between 24 and 28 weeks admitted to the antepartum service
Key exclusion criteria (4 listed)
- Patients with a non viable pregnancy
- Patients with multiple gestation
- Clinically Unstable patients
- Non English speaking patients
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 |
|---|---|---|
| Fetal Heart Rate MonitorStandard of care, not part of research | Other | – |
Primary outcome
To compare the amount of time that the fetal heart tones are traced in babies just at or beyond viability using a traditional device compared to the Monica device
Time frame: How long can hetal heart tracings be capture continuously
This study is to compare the amount of time that the fetal heart tones are traced in babies just at or beyond viability using a traditional device compared to the Monica device.
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 5 Aug 2016.
- Individual participant dataSharing planned: No
Related trials for Fetal Heart Tracing
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Labor
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.
Gary Fruhman, MD principal investigator
St. Louis 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 Fetal Heart Tracing, run by St. Louis University 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 1 inclusion and 4 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 5 Aug 2016. 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 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?
To compare the amount of time that the fetal heart tones are traced in babies just at or beyond viability using a traditional device compared to the Monica device (time frame: How long can hetal heart tracings be capture continuously). 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 5 Aug 2016.