Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy

Phase 3

Withdrawn

• Conditions: Menorrhagia; Endometrial Biopsy; Cervical Ripening
• Interventions: Drug: Misoprostol; Drug: Placebo

• Registration Number: NCT00953641
• Lead Sponsor: University of Saskatchewan

Brief Summary

The purpose of this study is to determine whether using Misoprostol vaginally before an office endometrial biopsy is performed, will make it easier, more successful and less painful to do the procedure.

The investigators' hypothesis is that vaginal Misoprostol 12 hours prior to endometrial biopsy will increase the ease of performing office endometrial biopsy by reducing the need to use a tenaculum or a cervical dilator to achieve passage of a biopsy pipelle.

Detailed Description

Endometrial biopsy is a common gynecological office procedure performed to assist in the pathological diagnosis of abnormal vaginal bleeding. The procedure can be painful and it may be difficult to obtain an endometrial sample with a hard and closed cervix. Giving Misoprostol before the procedure may soften the cervix sufficiently to allow an easier and more successful test. This medication has been tested before hysteroscopy and in some patients it has been shown to be beneficial.

104 patients need to be recruited for this study. Participants will be divided according to pre-menopausal and post-menopausal status. Each of these groups will then be divided into a treatment arm (with Misoprostol) and a placebo arm. Participants will place a vaginal suppository containing either Misoprostol 400 ug or a placebo 12h or more before their appointment for the endometrial biopsy.

Study Timeline

• Study First Submitted: 2008-08-26
• Study First Submitted QC: 2009-08-05
• Study First Posted: 2009-08-06
• Study Start: 2011-09
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-11
• Last Update Posted: 2012-08-14
• Primary Completion: 2012-09
• Study Completion: 2012-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Patients with abnormal uterine bleeding
• Age over 35 years

Exclusion Criteria

• Pregnancy
• Allergy to or contraindication to prostaglandin use
• Active genital tract infections
• Bleeding disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-Menopausal 1	Misoprostol	Pre-Menopausal group, receiving Misoprostol
Pre-Menopausal 2	Placebo	Patients will insert a placebo vaginal suppository 12h or more prior to the endometrial biopsy
Post-Menopausal 1	Misoprostol	Post-Menopausal patients will insert a Misoprostol vaginal suppository 12h or more prior to the endometrial biopsy
Post-Menopausal 2	Placebo	Placebo vaginal suppository prior to the endometrial biopsy

Primary Outcome Measures

Name	Time	Method
Evaluating the ease of an endometrial biopsy by the need to use a tenaculum or a cervical dilator to achieve passage of a biopsy pipelle	1 year

Secondary Outcome Measures

Name	Time	Method
Evaluating participants discomfort during the procedure, using a pain scale	1 year
Success rate of passage of the pipelle	1 year
Adverse effects from medications	1 year
Complications of the procedure	1 year

Trial Locations

Locations (1)

Obstetrics and Gynecologic Consultants; 🇨🇦 Saskatoon, Saskatchewan, Canada