Clinical trial NCT04247555: Cervix Monitor for Detection Conditions Leading to Spontaneous Preterm Delivery
Official title: Cervix Monitor for Elasticity and Length Measurements
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preterm Birth
Lead sponsor: Advanced Tactile Imaging, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Rutgers, The State University of New Jersey
name: St. Luke's Hospital and Health Network, Pennsylvania
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-01-30
Enrollment: 270
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Gestational age from 24 to 28 weeks at time of Cervix Monitor measurement
* Singleton in the current pregnancy

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Cervix elasticity
timeFrame: During examination procedure
measure: Cervix Length
timeFrame: During examination procedure
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers The State University Of New Jersey
state: New Jersey
city: Bethlehem
country: United States
facility: St. Luke's University Health Network Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine (MFM)
state: Pennsylvania
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.
citation: Lucente 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.