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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01769131

Acronym

OB39

Enrollment

Registered

2013-01-16

Start date

2012-09-30

Completion date

2014-12-31

Last updated

2015-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

cervix, Allis, Tenaculum, gynecology

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 89 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
A comparison of two instruments for stabilization of the cervix during office procedures	1 year	Primary - to determine the presence of a difference in pain perception between the two instruments.

Secondary

Measure	Time frame	Description
A comparison of two instruments for stabilization of the cervix during office procedures	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.

Countries

United States

Outcome results