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Non-Invasive Non-Ionizing Polarized Imaging System to Assess Structure of Cervix
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), June 2009
First Received: August 7, 2009   Last Updated: August 24, 2009   History of Changes
Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00955864
  Purpose

The uterine cervix is composed of muscle and collagen which changes as women age and under hormonal influences like after puberty, during pregnancy, and with menopause. It has been determined that during pregnancy, prior to cervical ripening, cross linked collagen fibrils are organized in tight bundles which provide tensile strength, rigidity and stiffness. As the cervix ripens in preparation for labor, cervical collagen concentration is decreases and solubility increases. However there are no noninvasive techniques available to evaluate such structural changes especially of the collagen of cervix. Developing a non-invasive way to evaluate the characteristics of cervical structure and collagen may aid in identifying women who are at risk of early cervical dilation. A specially designed polarized camera attached to a conventional colposcope can be used to take cervical images. Analyzing these images may enable us to visualize the collagen network in cervix. The purpose of this study is to explore the usefulness of polarized camera images in evaluating the cervical structure of healthy women at different ages. After evaluating and validating this approach in healthy, nonpregnant women, we plan to assess the cervical structure of pregnant women some of whom may be at risk of early cervical dilation.


Condition
Cervix Structure
Colposcope

Study Type: Observational
Official Title: Non-Invasive Non-Ionizing Polarized Imaging System to Assess Structure of Cervix

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 10
Study Start Date: July 2009
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Detailed Description:

The uterine cervix is composed of muscle and collagen which changes as women age and under hormonal influences like after puberty, during pregnancy, and with menopause. It has been determined that during pregnancy, prior to cervical ripening, cross linked collagen fibrils are organized in tight bundles which provide tensile strength, rigidity and stiffness. As the cervix ripens in preparation for labor, cervical collagen concentration is decreases and solubility increases. However there are no noninvasive techniques available to evaluate such structural changes especially of the collagen of cervix. Developing a non-invasive way to evaluate the characteristics of cervical structure and collagen may aid in identifying women who are at risk of early cervical dilation. A specially designed polarized camera attached to a conventional colposcope can be used to take cervical images. Analyzing these images may enable us to visualize the collagen network in cervix. The purpose of this study is to explore the usefulness of polarized camera images in evaluating the cervical structure of healthy women at different ages. After evaluating and validating this approach in healthy, nonpregnant women, we plan to assess the cervical structure of pregnant women some of whom may be at risk of early cervical dilation.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA
  • Age female 18 year or greater who are having regular menstrual cycles and are not on hormonal medications.

Healthy women without significant medical problems who have a uterine cervix.

EXCLUSION CRITERIA

  • Those with symptoms or signs of infection or are currently menstruating.
  • Any medical condition that, in the opinion of Principal Investigator, would preclude the inclusion of a patient onto this research study.
  • Unable or unwilling to give informed consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00955864

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Additional Information:
Publications:
Study ID Numbers: 090180, 09-CH-0180
Study First Received: August 7, 2009
Last Updated: August 24, 2009
ClinicalTrials.gov Identifier: NCT00955864     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Cervix
Colposcope
Polarized Light
Cervix Structure
Collagen

ClinicalTrials.gov processed this record on September 11, 2009