N/A
N=70
Endometrial Biopsy Instrument Comparison Study
Pain
Bottom Line
View on ClinicalTrials.gov: NCT00613925 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: 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). — 62.1; 69.1 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pipelle de Cornier (Device); Explora curette (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Oregon Health and Science University
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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). |
62.1; 69.1 | — |
| SECONDARY Sample Adequacy |
91.2; 98.6 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00613925). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.