Pregnancy PretermPTLNCT03785795
Multichannel EMG Diagnosing True Preterm Labor
An observational study of Pregnancy Preterm and Labor; Irregular, run by PreTeL, Inc at 1 site in United States.
Trial summary
We have designed new electromyography sensors for measuring uterine activity. These sensors are directional - they preferentially report uterine muscle contractions at specific locations, called regions. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Preterm, Labor; Irregular, Preterm Labor
- What is being tested?
- Uncertain diagnosis of true labor
- Type of treatment
- Medical device
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2018to 10 Jan 2020
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women with viable pregnancies who are experiencing uterine contractions will be studied. For each subject, her provider will not be certain if she is in true labor, or is experiencing false labor contractions. Other than experiencing contractions, subjects will have uncomplicated pregnancies. She will not have an indication for immediate delivery.
Who may be able to join
- Pregnant
- One living fetus
- Experiencing frequent uterine contractions
Who cannot join
- Cervical dilation > 4 cm
- Ruptured membranes
- Maternal or fetal indications for immediate delivery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing and Validating an EMG-based Fetal Monitor to Identify True Preterm Labor
We have designed new electromyography sensors for measuring uterine activity. These sensors are directional - they preferentially report uterine muscle contractions at specific locations, called regions. By measuring the synchronization of the regions of the uterus during contractions we intend to non-invasively determine if any patient is in-labor or not-in-labor. Accurately diagnosing true preterm labor allows timely intervention to avoid preterm birth; Accurately diagnosing false preterm labor avoids needlessly treating patients who would not benefit.
Read the detailed description
The legacy device for assessing uterine contractions is the tocodynamometer (Toco). The Toco is plunger-driven device that measures the uterine shape change that occurs with a contraction. Toco only reports the timing of contractions, not the contraction strength, and cannot distinguish between false and true labor.
Our overarching goal is to validate our method of determining if a patient experiencing contractions is in true labor or false labor. We will accomplish this by applying new knowledge to an old technology - uterine EMG.
This trial is based on our advanced understanding of how the uterus generates coordinated contractions without a pacemaker or dedicated electrical conduction pathways - mechanotransduction and intrauterine pressure - but also uses bioelectrical signaling for local tissue recruitment.
The uterus emits bioelectrical signals with each contraction that can be detected by electromyography (EMG). To observe uterine bioelectrical signals, we created a novel EMG sensor, we call the "area sensor". This sensor is directional - capable of preferentially reporting muscle contractions from immediately below the sensor location.
In this clinical trial we use multiple area sensors placed on the maternal abdomen to directly observe how well the regional contractions are synchronized. Our hypothesis to be tested is that highly synchronized contractions predicts true labor, unsynchronized predicts false labor.
Patients with unclear labor status, or those in early labor will be studied. We will correlate the results of the synchronization analysis against the patient's progress over the ensuing 24 hours. These data will validate the ability to identify false and true labor using multichannel EMG and area sensors.
- Conditions
- Pregnancy Preterm, Labor; Irregular, Preterm Labor
- Being tested
- Uncertain diagnosis of true labor
- Keywords
- Preterm labor detection, Labor detection, False labor
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uncertain diagnosis of true laborDevice
Multichannel EMG of uterine bioelectrical signals will be recorded using area sensors. The output of the synchronization calculations will be correlated with the time to delivery
| Study group | Role | What they receive |
|---|---|---|
| Uncertain diagnosis of true labor | Patients who cannot be accurately classified as experiencing true labor or false labor based on standard clinical assessments. Receives: Device: Uncertain diagnosis of true labor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validating prediction of true/false labor status with delivery within 24 hours
The test device predicts delivery. The prediction on each subject will be compared against the observed delivery time.
Measured: 24 hours
Secondary outcomes (1)
Establishing the range and trend of synchronized sensor readings
The fraction of EMG channels active during each contraction, and the running average of the fraction, will be correlated with time to delivery
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start25 Nov 2018
- Primary completion10 Jan 2020
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy PretermStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- PreTeL, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Rochester
- Responsible party
- Sponsor
- Investigators
- Roger C Young, MD, Principal investigator, PreTeL, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785795
- Sponsor's protocol ID
- SBIR1.01
- Acronym
- PTL
- Status last verified
- Feb 2020
- First submitted
- 19 Dec 2018
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Specific patient EMG tracings may be shared based on unique characteristics of pregnancy subsets.
Publications
Young RC. Mechanotransduction mechanisms for coordinating uterine contractions in human labor. Reproduction. 2016 Aug;152(2):R51-61. doi: 10.1530/REP-16-0156. Epub 2016 May 10.
PubMed 27165050
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing and Validating an EMG-based Fetal Monitor to Identify True Preterm Labor
- ClinicalTrials.gov ID
- NCT03785795
- Acronym / sponsor ID
- PTL / SBIR1.01
- Conditions
- Pregnancy Preterm, Labor; Irregular, Preterm Labor
- Keywords
- Preterm labor detection, Labor detection, False labor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- PreTeL, IncIndustry (pharma, biotech, devices)
- Collaborators
- University of Rochester
- Study start
- 25 Nov 2018 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 24 Dec 2018 (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.
We have designed new electromyography sensors for measuring uterine activity. These sensors are directional - they preferentially report uterine muscle contractions at specific locations, called regions. By measuring the synchronization of the regions of the uterus during contractions we intend to non-invasively determine if any patient is in-labor or not-in-labor. Accurately diagnosing true preterm labor allows timely intervention to avoid preterm birth; Accurately diagnosing false preterm labor avoids needlessly treating patients who would not benefit.
Detailed description
The legacy device for assessing uterine contractions is the tocodynamometer (Toco). The Toco is plunger-driven device that measures the uterine shape change that occurs with a contraction. Toco only reports the timing of contractions, not the contraction strength, and cannot distinguish between false and true labor.
Our overarching goal is to validate our method of determining if a patient experiencing contractions is in true labor or false labor. We will accomplish this by applying new knowledge to an old technology - uterine EMG.
This trial is based on our advanced understanding of how the uterus generates coordinated contractions without a pacemaker or dedicated electrical conduction pathways - mechanotransduction and intrauterine pressure - but also uses bioelectrical signaling for local tissue recruitment.
The uterus emits bioelectrical signals with each contraction that can be detected by electromyography (EMG). To observe uterine bioelectrical signals, we created a novel EMG sensor, we call the "area sensor". This sensor is directional - capable of preferentially reporting muscle contractions from immediately below the sensor location.
In this clinical trial we use multiple area sensors placed on the maternal abdomen to directly observe how well the regional contractions are synchronized. Our hypothesis to be tested is that highly synchronized contractions predicts true labor, unsynchronized predicts false labor.
Patients with unclear labor status, or those in early labor will be studied. We will correlate the results of the synchronization analysis against the patient's progress over the ensuing 24 hours. These data will validate the ability to identify false and true labor using multichannel EMG and area sensors.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Uncertain diagnosis of true labor | – | Device: Uncertain diagnosis of true laborPatients who cannot be accurately classified as experiencing true labor or false labor based on standard clinical assessments. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women with viable pregnancies who are experiencing uterine contractions will be studied. For each subject, her provider will not be certain if she is in true labor, or is experiencing false labor contractions. Other than experiencing contractions, subjects will have uncomplicated pregnancies. She will not have an indication for immediate delivery.
Key inclusion criteria (3 listed)
- Pregnant
- One living fetus
- Experiencing frequent uterine contractions
Key exclusion criteria (3 listed)
- Cervical dilation > 4 cm
- Ruptured membranes
- Maternal or fetal indications for immediate delivery
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 |
|---|---|---|
| Uncertain diagnosis of true laborMultichannel EMG of uterine bioelectrical signals will be recorded using area sensors. The output of the synchronization calculations will be correlated with the time to delivery | Device | Uncertain diagnosis of true labor |
Primary outcome
Validating prediction of true/false labor status with delivery within 24 hours
Time frame: 24 hours
The test device predicts delivery. The prediction on each subject will be compared against the observed delivery time.
1 secondary outcome
Establishing the range and trend of synchronized sensor readings
Time frame: 48 hours
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 12 Feb 2020.
- Background: PubMed 27165050Young RC. Mechanotransduction mechanisms for coordinating uterine contractions in human labor. Reproduction. 2016 Aug;152(2):R51-61. doi: 10.1530/REP-16-0156. Epub 2016 May 10.
- Individual participant dataSharing planned: Undecided. Specific patient EMG tracings may be shared based on unique characteristics of pregnancy subsets.
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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.
Roger C Young, MD principal investigator
PreTeL, Inc
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 Preterm and Labor; Irregular, run by PreTeL, Inc 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 3 inclusion and 3 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 12 Feb 2020. 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?
Validating prediction of true/false labor status with delivery within 24 hours (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03785795, which also lists 1 linked publication.
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 12 Feb 2020.