Preterm BirthCMNCT04247555
Cervix Monitor for Detection Conditions Leading to Spontaneous Preterm Delivery
An observational study of Preterm Birth, run by Advanced Tactile Imaging, Inc. at 2 sites in United States.
Trial summary
Preterm birth is a leading cause of neonatal mortality despite of numerous advances and intensive research in perinatal medicine. Almost one million children die every year due to the complications of preterm birth and rates are on the rise. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Preterm Birth
- How many people
- 270 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Jan 2020to 31 Mar 2022
- 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
- Child, Adult, Older adult
Study population: Woman at 24 to 28 weeks of pregnancy scheduled for a regular examination at the Divisions of Maternal Fetal Medicine will be considered eligible for this study enrollment.
Who may be able to join
- Gestational age from 24 to 28 weeks at time of Cervix Monitor measurement
- Singleton in the current pregnancy
Who cannot join
- Fatal anomaly
- History of fetal reduction in the current pregnancy to the singleton gestation
- Preterm rapture of membranes
- Current or planned cervical cerclage
- Planned indicated preterm delivery
- Active known cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder
- Ischemic heart disease and or arrhythmia
- Active skin infection or ulceration within the vaginal/vulva (Herpes infection)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
St. Luke's University Health Network Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine (MFM)
Bethlehem, Pennsylvania, 18015
Rutgers The State University Of New Jersey
New Brunswick, New Jersey, 08854
About this study
Official title: Cervix Monitor for Elasticity and Length Measurements
Preterm birth is a leading cause of neonatal mortality despite of numerous advances and intensive research in perinatal medicine. Almost one million children die every year due to the complications of preterm birth and rates are on the rise. Of the 14 million survivors per year, most face a lifetime of disability, including learning disabilities, visual and hearing impairments. The majority of preterm birth happen spontaneously (SPTD) which is often a multi factorial event, precocious cervical softening, shortening and dilatation are a common underlying factor. In the scope of this project the investigators propose to develop and clinically validate a new device, Cervix Monitor (CM), for detecting cervix conditions leading to SPTD and its risk assessment.
Read the detailed description
SPTD is closely related to a premature cervical ripening. The scientific basis for the proposed project is that the elasticity modulus of a cervix is a more sensitive parameter characterizing the stage of cervical ripening. The main component of the cervical tissue is collagen. Cervical ripening is the result of realignment of collagen, degradation of collagen cross-linking due to proteolytic enzymes. These processes affect the elasticity modulus of the cervical tissue. Therefore, assessment of cervix by a device (CM) measuring cervical elasticity (stiffness) and cervical length (effacement) appears to be an adequate approach for identifying pregnant women at high risk of SPTD. The CM is based on measuring applied pressure to the cervix by a tactile sensor array (stress data) and ultrasound measurement of cervix length (strain data). Tactile and ultrasound sensors are allocated on the tip of the measuring part of vaginal probe. The discovery of novel bio markers that could reliably identify women who will subsequently deliver preterm, may allow for timely medical intervention and targeted therapeutic treatments aimed at improving maternal and fetal outcomes.
- Conditions
- Preterm Birth
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervix elasticity
Units measurement of elasticity in kPa
Measured: During examination procedure
Cervix Length
Units of measurement of length in mm
Measured: During examination procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start3 Jan 2020
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advanced Tactile Imaging, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rutgers, The State University of New Jersey, St. Luke's Hospital and Health Network, Pennsylvania, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Vladimir Egorov, PhD, Principal investigator, Advanced Tactile Imaging, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247555
- Sponsor's protocol ID
- CM02
- Other IDs
- R44HD090793
- Acronym
- CM
- Status last verified
- Jul 2021
- First submitted
- 28 Jan 2020
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Egorov V, Rosen T, van Raalte H, Kurtenoks V. Cervical Characterization with Tactile-Ultrasound Probe. Open J Obstet Gynecol. 2020 Jan;10(1):85-99. doi: 10.4236/ojog.2020.101008. Epub 2020 Jan 8.
PubMed 32133244Lucente V, van Raalte H, Murphy M, Egorov V. Biomechanical paradigm and interpretation of female pelvic floor conditions before a treatment. Int J Womens Health. 2017 Aug 3;9:521-550. doi: 10.2147/IJWH.S136989. eCollection 2017.
PubMed 28831274
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervix Monitor for Elasticity and Length Measurements
- ClinicalTrials.gov ID
- NCT04247555
- Acronym / sponsor ID
- CM / CM02
- Conditions
- Preterm Birth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Advanced Tactile Imaging, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Rutgers, The State University of New Jersey, St. Luke's Hospital and Health Network, Pennsylvania, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 30 Jan 2020 (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.
Preterm birth is a leading cause of neonatal mortality despite of numerous advances and intensive research in perinatal medicine. Almost one million children die every year due to the complications of preterm birth and rates are on the rise. Of the 14 million survivors per year, most face a lifetime of disability, including learning disabilities, visual and hearing impairments. The majority of preterm birth happen spontaneously (SPTD) which is often a multi factorial event, precocious cervical softening, shortening and dilatation are a common underlying factor. In the scope of this project the investigators propose to develop and clinically validate a new device, Cervix Monitor (CM), for detecting cervix conditions leading to SPTD and its risk assessment.
Detailed description
SPTD is closely related to a premature cervical ripening. The scientific basis for the proposed project is that the elasticity modulus of a cervix is a more sensitive parameter characterizing the stage of cervical ripening. The main component of the cervical tissue is collagen. Cervical ripening is the result of realignment of collagen, degradation of collagen cross-linking due to proteolytic enzymes. These processes affect the elasticity modulus of the cervical tissue. Therefore, assessment of cervix by a device (CM) measuring cervical elasticity (stiffness) and cervical length (effacement) appears to be an adequate approach for identifying pregnant women at high risk of SPTD. The CM is based on measuring applied pressure to the cervix by a tactile sensor array (stress data) and ultrasound measurement of cervix length (strain data). Tactile and ultrasound sensors are allocated on the tip of the measuring part of vaginal probe. The discovery of novel bio markers that could reliably identify women who will subsequently deliver preterm, may allow for timely medical intervention and targeted therapeutic treatments aimed at improving maternal and fetal outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- Woman at 24 to 28 weeks of pregnancy scheduled for a regular examination at the Divisions of Maternal Fetal Medicine will be considered eligible for this study enrollment.
Key inclusion criteria (2 listed)
- Gestational age from 24 to 28 weeks at time of Cervix Monitor measurement
- Singleton in the current pregnancy
Key exclusion criteria (8 listed)
- Fatal anomaly
- History of fetal reduction in the current pregnancy to the singleton gestation
- Preterm rapture of membranes
- Current or planned cervical cerclage
- Planned indicated preterm delivery
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
Cervix elasticity
Time frame: During examination procedure
Units measurement of elasticity in kPa
Cervix Length
Time frame: During examination procedure
Units of measurement of length in mm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Background: PubMed 32133244Egorov V, Rosen T, van Raalte H, Kurtenoks V. Cervical Characterization with Tactile-Ultrasound Probe. Open J Obstet Gynecol. 2020 Jan;10(1):85-99. doi: 10.4236/ojog.2020.101008. Epub 2020 Jan 8.
- Background: PubMed 28831274Lucente V, van Raalte H, Murphy M, Egorov V. Biomechanical paradigm and interpretation of female pelvic floor conditions before a treatment. Int J Womens Health. 2017 Aug 3;9:521-550. doi: 10.2147/IJWH.S136989. eCollection 2017.
- Individual participant dataSharing planned: No
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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.
Vladimir Egorov, PhD principal investigator
Advanced Tactile Imaging, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth, run by Advanced Tactile Imaging, Inc. at 2 sites 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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Cervix elasticity (time frame: During examination procedure). 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?
On the ClinicalTrials.gov record for NCT04247555, which also lists 2 linked publications.
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 21 Jul 2021.