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A Comparison of Two Instruments for Stabilization of the Cervix During Office Procedures (OB39)

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ClinicalTrials.gov Identifier: NCT01769131
Recruitment Status : Completed
First Posted : January 16, 2013
Last Update Posted : August 4, 2015
Sponsor:
Information provided by (Responsible Party):
Isaiah Johnson, Carilion Clinic

Brief Summary:

An Allis clamp causes less pain and bleeding than a single tooth tenaculum when used for mobilization of the cervix during common gynecologic office procedures.

The primary object is to determine the presence of a difference in pain perception between the two instruments.

The secondary objective is to evaluate the differences in the frequency of bleeding, that requires treatment, after removal of the instrument and the need to use an alternative instruments.


Condition or disease
Comparing Two Clamps for Mobilization of the Cervix During Common Gynecologic Office Procedures

Study Type : Observational
Actual Enrollment : 81 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Comparison of Two Instruments for Stabilization of the Cervix During Office Procedures
Study Start Date : September 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Group/Cohort
Allis
Tenaculum



Primary Outcome Measures :
  1. A comparison of two instruments for stabilization of the cervix during office procedures [ Time Frame: 1 year ]
    Primary - to determine the presence of a difference in pain perception between the two instruments.


Secondary Outcome Measures :
  1. A comparison of two instruments for stabilization of the cervix during office procedures [ Time Frame: 1 year ]
    Secondary - To evaluate the differences in the frequency of bleeding, that required treatment, after removal of the instruct and the need to use an alternative instrument.



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Females between the ages of 18 and 89 years undergoing an IUD placement
Criteria

Inclusion Criteria:

  • Female
  • Between 18 and 89 years of age
  • Undergoing an IUD placement

Exclusion Criteria:

  • IUD placement within the last 6 months
  • Active cervical or pelvic infection
  • pregnant
  • Patient taking coagulation medications

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): NCT01769131


Locations
United States, Virginia
Carilion Clinic
Roanoke, Virginia, United States, 24014
Sponsors and Collaborators
Carilion Clinic

Responsible Party: Isaiah Johnson, Physician, Carilion Clinic
ClinicalTrials.gov Identifier: NCT01769131     History of Changes
Other Study ID Numbers: OB39
First Posted: January 16, 2013    Key Record Dates
Last Update Posted: August 4, 2015
Last Verified: August 2015

Keywords provided by Isaiah Johnson, Carilion Clinic:
cervix
Allis
Tenaculum
gynecology