Endometrial Biopsy Instrument Comparison Study

Not Applicable

Completed

• Conditions: Pain
• Interventions: Device: Pipelle de Cornier; Device: Explora curette

• Registration Number: NCT00613925
• Lead Sponsor: Oregon Health and Science University

Brief Summary

The purpose of this study is to determine the level of pain women experience during an endometrial biopsy and the effect that the biopsy tool might have on that pain. The investigators will also evaluate the adequacy of the sample each endometrial biopsy tool collects.

Detailed Description

Is there a difference in pain perceived by patients undergoing endometrial biopsy via the Pipelle or Explora curette? Currently, the instrument selected for endometrial biopsy is solely dependent on provider preference. This study aims to elucidate advantages and/or disadvantages of the Pipelle versus the Explora curette in terms of pain perceived by the patient, adequacy of sample, and provider ease of use to better aid in the selection of the appropriate device.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-31
• Study First Submitted QC: 2008-01-31
• Study First Posted: 2008-02-13
• Primary Completion: 2009-01
• Study Completion: 2011-01
• Results First Submitted: 2012-06-04
• Status Verified: 2014-04
• Results First Submitted QC: 2014-04-07
• Last Update Submitted: 2014-04-07
• Results First Posted: 2014-05-12
• Last Update Posted: 2014-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 73

Inclusion Criteria

• Women ages 18 and over who present to the Oregon Health and Science University Center for Women's Health and the Portland Veteran's Affairs Medical Center with an indication for endometrial biopsy, are literate in English or Spanish, who are willing to participate in the study.

Exclusion Criteria

• Pregnancy, known or suspected
• Known cervical stenosis
• History of Mullerian tract anomalies
• History of uterine or cervical surgery
• Pelvic inflammatory disease (current or within the past 3 months)
• Sexually transmitted diseases (current)
• Puerperal or post abortion sepsis (current or within the past 3 months)
• Purulent cervicitis (current)
• Known clotting disorder
• Known uterine anomalies or fibroids distorting the cavity in a way incompatible with office endometrial biopsy
• Allergy to any component of the Pipelle or Explora curette
• Patients who are premedicated with analgesics or misoprostol
• Patients who require mechanical cervical dilation or receive paracervical block

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pipelle Group	Pipelle de Cornier	Women were randomized to have an endometrial biopsy collected using Pipelle de Cornier instrument.
Explora group	Explora curette	Women were randomized to have an endometrial biopsy collected using Explora curette instrument.

Primary Outcome Measures

Name	Time	Method
Compare Pipelle and Explora Curette Groups With Respect to Patient Perception of Pain Associated With the Procedure as Rated by a 100mm Visual Analog Scale (VAS).	2 minutes after biopsy procedure	The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0="No Pain" (furthest point to the left) to 100="Worst Pain in My Life" (furthest point to the right).

Secondary Outcome Measures

Name	Time	Method
Sample Adequacy	at time of biopsy	adequacy of sample obtained for examination by a pathologist

Trial Locations

Locations (2)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

Portland Veterans Affairs Medical Center; 🇺🇸 Portland, Oregon, United States