Preterm BirthNCT03199079
Cervix Monitor for Elasticity and Length Measurements
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 global cause of neonatal mortality despite of numerous advances and intensive research in perinatal medicine. Almost one million children die each year due to complications of preterm birth and in almost all countries with reliable data, preterm birth rates are increasing. Read more about this study
- Who is it for?
- Ages 21 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Measurement
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2017to 11 Oct 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Conditions precluding patients from participation are listed in the study exclusion criteria below. In addition, cognitively impaired patients will not be asked to participate. No patients will be excluded on the basis of race.
Who may be able to join
- Adult women age 21-44 years
- Non-pregnant women, or
- Pregnant women
Who cannot join
- Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder
- Ongoing or prior radiation therapy for abdominal or pelvic cancer
- Recent (less than four months) pelvic surgery
- Surgically absent uterus, rectum or bladder
- Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician
- Severe abdominal or pelvic adhesions preventing access to pertinent anatomy
Show all 13Show fewer
- Known or suspected bleeding disorder
- HIV or hepatitis B positive serology
- Warty lesions on the vulva
- Extensive varicose veins on the vulva
- Active skin infection or ulceration within the vagina/vulva (Herpes infection)
- Presence of a vaginal septum
- Severe hemorrhoids
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08854
Princeton Urogynecology
Princeton, New Jersey, 08540
About this study
Official title: Cervix Monitor for Risk Assessment of Spontaneous Preterm Delivery
Preterm birth is a leading global cause of neonatal mortality despite of numerous advances and intensive research in perinatal medicine. Almost one million children die each year due to complications of preterm birth and in almost all countries with reliable data, preterm birth rates are increasing. Of the 14 million survivors per year, many face a lifetime of disability, including learning disabilities, visual and hearing impairments. Spontaneous preterm delivery (SPTD) is often multi factorial event, precocious cervical softening, shortening and dilatation are a common denominator. The majority of preterm births happen spontaneously, though some are due to early induction of labor or cesarean birth, typically due to medical maternal of neonatal conditions.
Read the detailed description
The uterine cervix has to provide structural integrity and mechanical resistance to ensure normal development of the fetus as the uterus expands to accommodate the fetus growth. Preterm delivery is closely related to a premature cervical ripening. The scientific bases for the proposed project is the elasticity modulus of a cervix is a more sensitive parameter characterizing the stage of cervical ripening. The main component of the cervix tissue is a 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 measuring cervical elasticity and cervical length appears to be and adequate approach for identifying pregnant women at high risk of spontaneous preterm delivery. The primary cervical elasticity assessment currently used in clinical practice is relying on the evaluation of the cervix as "hard, medium or soft". In the scope of this project the investigators propose to develop and clinically validate a new and cost-effective device, Cervix Monitor for detecting cervix conditions leading to SPTD and its risk assessment. The CM will be based on measuring of the applied pressure to the cervix by a tactile sensor array and ultrasound measurement of cervix length .
- Conditions
- Preterm Birth
- Being tested
- Measurement
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeasurementOther
Measurement of cervix elasticity and length measurements is not an intervention
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Non-pregnant women | Non-pregnant women with normal pelvic floor Receives: Other: Measurement | |
| Group 2: Pregnant women | Pregnant women; 22-29 weeks of pregnancy Receives: Other: Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervix Elasticity
Young's modulus of the cervix at 4 locations. Units of measurement is kPa.
Measured: During examination procedure
Secondary outcomes (1)
Cervix Length
Cervix 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 posted26 Jun 2017
- Study start1 May 2017
- Primary completion27 Apr 2022
- Study completion11 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Tactile Imaging, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Princeton Urogynecology, Rutgers, The State University of New Jersey
- Responsible party
- Sponsor
- Investigators
- Vladimir Egorov, PhD, Principal investigator, Advanced Tactile Imaging, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199079
- Sponsor's protocol ID
- CM01A/B
- Status last verified
- Apr 2020
- First submitted
- 22 May 2017
- Last updated
- 17 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- 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 32133244
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervix Monitor for Risk Assessment of Spontaneous Preterm Delivery
- ClinicalTrials.gov ID
- NCT03199079
- Acronym / sponsor ID
- CM01A/B
- Conditions
- Preterm Birth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Advanced Tactile Imaging, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Princeton Urogynecology, Rutgers, The State University of New Jersey
- Study start
- 1 May 2017 (actual)
- Primary completion
- 27 Apr 2022 (actual)
- Study completion
- 11 Oct 2022 (actual)
- First posted
- 26 Jun 2017 (actual)
- Results
- Posted 14 Apr 2020
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 global cause of neonatal mortality despite of numerous advances and intensive research in perinatal medicine. Almost one million children die each year due to complications of preterm birth and in almost all countries with reliable data, preterm birth rates are increasing. Of the 14 million survivors per year, many face a lifetime of disability, including learning disabilities, visual and hearing impairments. Spontaneous preterm delivery (SPTD) is often multi factorial event, precocious cervical softening, shortening and dilatation are a common denominator. The majority of preterm births happen spontaneously, though some are due to early induction of labor or cesarean birth, typically due to medical maternal of neonatal conditions.
Detailed description
The uterine cervix has to provide structural integrity and mechanical resistance to ensure normal development of the fetus as the uterus expands to accommodate the fetus growth. Preterm delivery is closely related to a premature cervical ripening. The scientific bases for the proposed project is the elasticity modulus of a cervix is a more sensitive parameter characterizing the stage of cervical ripening. The main component of the cervix tissue is a 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 measuring cervical elasticity and cervical length appears to be and adequate approach for identifying pregnant women at high risk of spontaneous preterm delivery. The primary cervical elasticity assessment currently used in clinical practice is relying on the evaluation of the cervix as "hard, medium or soft". In the scope of this project the investigators propose to develop and clinically validate a new and cost-effective device, Cervix Monitor for detecting cervix conditions leading to SPTD and its risk assessment. The CM will be based on measuring of the applied pressure to the cervix by a tactile sensor array and ultrasound measurement of cervix length .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Non-pregnant women | – | Other: MeasurementNon-pregnant women with normal pelvic floor |
| Group 2: Pregnant women | – | Other: MeasurementPregnant women; 22-29 weeks of pregnancy |
Who may qualify
- Ages
- 21 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Conditions precluding patients from participation are listed in the study exclusion criteria below. In addition, cognitively impaired patients will not be asked to participate. No patients will be excluded on the basis of race.
Key inclusion criteria (3 listed)
- Adult women age 21-44 years
- Non-pregnant women, or
- Pregnant women
Key exclusion criteria (13 listed)
- Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder
- Ongoing or prior radiation therapy for abdominal or pelvic cancer
- Recent (less than four months) pelvic surgery
- Surgically absent uterus, rectum or bladder
- Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician
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 |
|---|---|---|
| MeasurementMeasurement of cervix elasticity and length measurements is not an intervention | Other | Group 1: Non-pregnant women, Group 2: Pregnant women |
Primary outcome
Cervix Elasticity
Time frame: During examination procedure
Young's modulus of the cervix at 4 locations. Units of measurement is kPa.
1 secondary outcome
Cervix Length
Time frame: During examination procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: 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.
- 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 3 inclusion and 13 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 17 Oct 2022. 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?
Yes. Results are posted in the registry (first posted 14 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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). 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 NCT03199079, 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 17 Oct 2022.