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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Isaiah Johnson, Carilion Clinic
ClinicalTrials.gov Identifier:
NCT01769131
First received: January 14, 2013
Last updated: August 2, 2015
Last verified: August 2015
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Comparison of Two Instruments for Stabilization of the Cervix During Office Procedures

Further study details as provided by Carilion Clinic:

Primary Outcome Measures:
  • A comparison of two instruments for stabilization of the cervix during office procedures [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Primary - to determine the presence of a difference in pain perception between the two instruments.


Secondary Outcome Measures:
  • A comparison of two instruments for stabilization of the cervix during office procedures [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Enrollment: 81
Study Start Date: September 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Allis
Tenaculum

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Genders 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
  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: NCT01769131

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

Responsible Party: Isaiah Johnson, Physician, Carilion Clinic
ClinicalTrials.gov Identifier: NCT01769131     History of Changes
Other Study ID Numbers: OB39 
Study First Received: January 14, 2013
Last Updated: August 2, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Carilion Clinic:
cervix
Allis
Tenaculum
gynecology

ClinicalTrials.gov processed this record on July 21, 2016