- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01769131
A Comparison of Two Instruments for Stabilization of the Cervix During Office Procedures (OB39)
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
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Virginia
-
Roanoke, Virginia, United States, 24014
- Carilion Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- OB39
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