Endometrial Biopsy Instrument Comparison Study

Oregon Health & Science University (OHSU)

Status: Completed

Conditions: Pain

Treatments: Device: Explora curette; Device: Pipelle de Cornier

Study type: Interventional

Funder types: Other

Identifiers

NCT00613925

OHSU RES 4145

Details and patient eligibility

About

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.

Full 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.

Enrollment: 73 patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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73 participants in 2 patient groups

Pipelle Group

Active Comparator group

Description:

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

Treatment:

Device: Pipelle de Cornier

Explora group

Active Comparator group

Description:

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

Treatment:

Device: Explora curette