Clinical trial NCT00613925: Endometrial Biopsy Instrument Comparison Study
Official title: Comparison of Pain Experienced by Patients Undergoing Endometrial Biopsy by Pipelle and Explora Curette
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: endometrial biopsy
pain management
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2008-02-13
Enrollment: 73
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: 2 minutes after biopsy procedure
Secondary outcomes:
measure: Sample Adequacy
timeFrame: at time of biopsy
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Portland
country: United States
facility: Portland Veterans Affairs Medical Center
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Alison Edelman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.