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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date January 14, 2013
First Posted Date January 16, 2013
Last Update Posted Date August 4, 2015
Study Start Date September 2012
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 15, 2013)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 15, 2013)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Comparison of Two Instruments for Stabilization of the Cervix During Office Procedures
Official Title A Comparison of Two Instruments for Stabilization of the Cervix During Office Procedures
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Females between the ages of 18 and 89 years undergoing an IUD placement
Condition Comparing Two Clamps for Mobilization of the Cervix During Common Gynecologic Office Procedures
Intervention Not Provided
Study Groups/Cohorts
  • Allis
  • Tenaculum
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 2, 2015)
81
Original Estimated Enrollment
 (submitted: January 15, 2013)
78
Actual Study Completion Date December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01769131
Other Study ID Numbers OB39
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Isaiah Johnson, Carilion Clinic
Study Sponsor Carilion Clinic
Collaborators Not Provided
Investigators Not Provided
PRS Account Carilion Clinic
Verification Date August 2015