Non-Invasive Non-Ionizing Polarized Imaging System to Assess Structure of Cervix

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00955864
First received: August 7, 2009
Last updated: October 4, 2014
Last verified: September 2014
  Purpose

Background:

  • The uterine cervix is composed of muscle and collagen, which change as women age and under hormonal influences like puberty, pregnancy, and menopause. Yet even though knowledge of structure of the cervix (especially the collagen network) is important to detect problems that may affect pregnancy and other women s health issues, no noninvasive techniques are available to evaluate such changes.
  • A specially designed polarized camera attached to a conventional colposcope can be used to take cervical images. Analyzing these images may enable researchers to better visualize the collagen network in the cervix.

Objectives:

  • To explore and gain experience with the use of a polarized imaging system to study cervical structure.
  • To evaluate the usefulness of a polarized imaging system in studying the cervical structure of healthy nonpregnant women.

Eligibility:

- Adult females (at least 18 years of age) who are having regular menstrual cycles and are not on hormonal medications.

Design:

  • Images will be takes from the cervix in two different phases of menstruation cycle time, one in the follicular phase (before ovulation) and another one in the luteal phase (after ovulation).
  • The images of the cervix will be taken with a vaginal speculum in place with the camera attached to a colposcope. The colposcope will illuminate the cervix using polarized light. Three random cervical locations will be photographed

Condition
Healthy

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):

Enrollment: 12
Study Start Date: July 2009
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:   No
Criteria
  • INCLUSION CRITERIA:
  • Age female 18 year or greater including IUI patients. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955864

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Amir Gandjbakhche, Ph.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00955864     History of Changes
Other Study ID Numbers: 090180, 09-CH-0180
Study First Received: August 7, 2009
Last Updated: October 4, 2014
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on October 21, 2014