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: March 14, 2014
Last verified: October 2013

August 7, 2009
March 14, 2014
July 2009
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Complete list of historical versions of study NCT00955864 on ClinicalTrials.gov Archive Site
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Non-Invasive Non-Ionizing Polarized Imaging System to Assess Structure of Cervix
Non-Invasive Non-Ionizing Polarized Imaging System to Assess Structure of Cervix

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

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.

Observational
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Healthy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
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  • 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.
Female
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00955864
090180, 09-CH-0180
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: Amir Gandjbakhche, Ph.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health Clinical Center (CC)
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP