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

August 2, 2015 updated by: Isaiah Johnson, Carilion Clinic

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

81

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Carilion Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Females between the ages of 18 and 89 years undergoing an IUD placement

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Allis
Tenaculum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

January 14, 2013

First Submitted That Met QC Criteria

January 15, 2013

First Posted (ESTIMATE)

January 16, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 4, 2015

Last Update Submitted That Met QC Criteria

August 2, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • OB39

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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