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Cervix Monitor for Elasticity and Length Measurements

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ClinicalTrials.gov Identifier: NCT03199079
Recruitment Status : Completed
First Posted : June 26, 2017
Last Update Posted : February 19, 2018
Sponsor:
Collaborators:
Princeton Urogynecology
Rutgers, The State University of New Jersey
Information provided by (Responsible Party):
Advanced Tactile Imaging, Inc.

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.

Condition or disease Intervention/treatment
Preterm Birth Device: Cervix Monitor

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 .

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Cervix Monitor for Risk Assessment of Spontaneous Preterm Delivery
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : January 5, 2018
Actual Study Completion Date : February 14, 2018

Group/Cohort Intervention/treatment
Group 1: Non-pregnant women
Non-pregnant women with normal pelvic floor
Device: Cervix Monitor
Cervix elasticity and length measurements by Cervix Monitor

Group 2: Pregnant women
Pregnant women; 22-29 weeks of pregnancy
Device: Cervix Monitor
Cervix elasticity and length measurements by Cervix Monitor




Primary Outcome Measures :
  1. Cervix elasticity [ Time Frame: During examination procedure ]
    Young's modulus of the cervix at 4 locations. Units of measurement is kPa.


Secondary Outcome Measures :
  1. Cervix length [ Time Frame: During examination procedure ]
    Cervix length in mm



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Ages Eligible for Study:   21 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Adult women
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199079


Locations
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United States, New Jersey
Princeton Urogynecology
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Advanced Tactile Imaging, Inc.
Princeton Urogynecology
Rutgers, The State University of New Jersey
Investigators
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Study Director: Heather van Raalte, MD Princeton Urogynecology
Study Director: Todd Joshua Rosen, MD Rutgers, The State University of New Jersey

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Responsible Party: Advanced Tactile Imaging, Inc.
ClinicalTrials.gov Identifier: NCT03199079     History of Changes
Other Study ID Numbers: CM01A/B
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications