Clinical trial NCT03199079: Cervix Monitor for Elasticity and Length Measurements
Official title: Cervix Monitor for Risk Assessment of Spontaneous Preterm Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Birth
Lead sponsor: Advanced Tactile Imaging, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Princeton Urogynecology
name: Rutgers, The State University of New Jersey
First posted: 2017-06-26
Enrollment: 20
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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 .

Eligibility criteria: Inclusion Criteria:

1. Adult women age 21-44 years
2. Non-pregnant women, or
3. Pregnant women

Exclusion Criteria:

1. Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder
2. Ongoing or prior radiation therapy for abdominal or pelvic cancer
3. Recent (less than four months) pelvic surgery
4. Surgically absent uterus, rectum or bladder
5. Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician
6. Severe abdominal or pelvic adhesions preventing access to pertinent anatomy
7. Known or suspected bleeding disorder
8. HIV or hepatitis B positive serology
9. Warty lesions on the vulva
10. Extensive varicose veins on the vulva
11. Active skin infection or ulceration within the vagina/vulva (Herpes infection)
12. Presence of a vaginal septum
13. Severe hemorrhoids

Primary outcomes:
measure: Cervix Elasticity
timeFrame: During examination procedure
Secondary outcomes:
measure: Cervix Length
timeFrame: During examination procedure
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson Medical School
state: New Jersey
city: Princeton
country: United States
facility: Princeton Urogynecology
state: New Jersey
Study officials:
affiliation: Advanced Tactile Imaging, Inc.
name: Vladimir Egorov, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.