Cervix Monitor for Elasticity and Length Measurements

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.

Study Overview

• Status: Completed
• Conditions: Preterm Birth
• Intervention / Treatment: Other: Measurement

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08854
      • Rutgers Robert Wood Johnson Medical School
    • Princeton, New Jersey, United States, 08540
      • Princeton Urogynecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 44 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1: Non-pregnant women; Non-pregnant women with normal pelvic floor	Other: Measurement; Measurement of cervix elasticity and length measurements is not an intervention
Group 2: Pregnant women; Pregnant women; 22-29 weeks of pregnancy	Other: Measurement; Measurement of cervix elasticity and length measurements is not an intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cervix Elasticity	Young's modulus of the cervix at 4 locations. Units of measurement is kPa.	During examination procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cervix Length	Cervix length in mm	During examination procedure

Collaborators and Investigators

• Sponsor: Advanced Tactile Imaging, Inc.
• Collaborators: Rutgers, The State University of New Jersey; Princeton Urogynecology
• Investigators: Principal Investigator: Vladimir Egorov, PhD, Advanced Tactile Imaging, Inc.

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): April 27, 2022
• Study Completion (Actual): October 11, 2022

Study Registration Dates

• First Submitted: May 22, 2017
• First Submitted That Met QC Criteria: June 22, 2017
• First Posted (Actual): June 26, 2017

Study Record Updates

• Last Update Posted (Actual): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: CM01A/B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No