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

NCT ID: NCT01769131

Last Updated: 2015-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Allis

No interventions assigned to this group

Tenaculum

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Carilion Clinic

OTHER

Sponsor Role lead

Responsible Party

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Isaiah Johnson

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Carilion Clinic

Roanoke, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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OB39

Identifier Type: -

Identifier Source: org_study_id

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