Cervix Monitor for Elasticity and Length Measurements

Preterm Birth Clinical Trial

Official title:

Cervix Monitor for Risk Assessment of Spontaneous Preterm Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03199079
• Other study ID #: CM01A/B
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: October 11, 2022

Study information

• Verified date: April 2020
• Source: Advanced Tactile Imaging, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 11, 2022
• Est. primary completion date: April 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Other:
• Measurement
Measurement of cervix elasticity and length measurements is not an intervention

Locations

Country	Name	City	State
United States	Rutgers Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Princeton Urogynecology	Princeton	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Advanced Tactile Imaging, Inc.	Princeton Urogynecology, Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cervix Elasticity	Young's modulus of the cervix at 4 locations. Units of measurement is kPa.	During examination procedure
Secondary	Cervix Length	Cervix length in mm	During examination procedure