NCT03199079

Cervix Monitor for Elasticity and Length Measurements

Cervix Monitor for Risk Assessment of Spontaneous Preterm Delivery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Advanced Tactile Imaging, Inc. · Industry
• Sex: Female
• Age: 21 Years – 44 Years
• Healthy volunteers: Accepted

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 .

Conditions

• Preterm Birth

Interventions

Type	Name	Description
OTHER	Measurement	Measurement of cervix elasticity and length measurements is not an intervention

Timeline

• Start date: 2017-05-01
• Primary completion: 2022-04-27
• Completion: 2022-10-11
• First posted: 2017-06-26
• Last updated: 2022-10-17
• Results posted: 2020-04-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study