Endometrial Biopsy Instrument Comparison Study

NCT00613925 | Completed Results

• 1 other identifier: OHSU RES 4145
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 2

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.

Conditions

Pain

Keywords

endometrial biopsy; pain management

Outcome Measures

Primary Outcomes (1)

• 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).

  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).

  2 minutes after biopsy procedure

Secondary Outcomes (1)

• Sample Adequacy

  at time of biopsy

Study Arms (2)

Pipelle Group

ACTIVE COMPARATOR

Women were randomized to have an endometrial biopsy collected using Pipelle de Cornier instrument.

Device: Pipelle de Cornier

Explora group

ACTIVE COMPARATOR

Women were randomized to have an endometrial biopsy collected using Explora curette instrument.

Device: Explora curette

Interventions

Pipelle de Cornier DEVICE

A flexible suction cannula 23.5 cm in length with an inner diameter of 2.6 mm and an outer diameter of 3.1 mm. It has a 2.4mm diameter opening on the distal end, on one side of the cannula. It is a disposable polypropylene sheath with an inner plunger and is used for blind endometrial biopsy.

Also known as: Pipelle

Pipelle Group

Explora curette DEVICE

The curette has an outer diameter of 3.0 mm and is slightly more rigid. This cannula has a sharp Randall-type cutting edge on the distal end, on one side of the cannula.

Also known as: Explora

Explora group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (2)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Portland Veterans Affairs Medical Center

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Leclair CM, Zia JK, Doom CM, Morgan TK, Edelman AB. Pain experienced using two different methods of endometrial biopsy: a randomized controlled trial. Obstet Gynecol. 2011 Mar;117(3):636-641. doi: 10.1097/AOG.0b013e31820ad45b.

  PMID: 21343767 RESULT

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Limitations and Caveats

Providers not blinded

Results Point of Contact

• Title: Alison Edelman, Associate Professor
• Organization: Oregon health & Science University

edelmana@ohsu.edu

503-418-2585

Study Officials

• Alison Edelman, MD, MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD MPH

Study Record Dates

• First Submitted: January 31, 2008
• First Posted: February 13, 2008
• Study Start: January 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2011
• Last Updated: May 12, 2014
• Results First Posted: May 12, 2014

Record last verified: 2014-04

Locations

US (2)