Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy

Menorrhagia Clinical Trial

Official title:

Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00953641
• Other study ID #: 07-134
• Status: Withdrawn
• Phase: Phase 3
• First received: August 26, 2008
• Last updated: August 11, 2012
• Start date: September 2011
• Est. completion date: September 2012

Study information

• Verified date: August 2012
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Ripening
• Endometrial Biopsy
• Menorrhagia

Intervention

Drug:
• Misoprostol
Misoprostol 400ug, suspended in a base (Witepsol 15) as a vaginal suppository Single dose 12h or more prior to the procedure
• Placebo
Witepsol 15 base, vaginal suppository, Single dose, 12h or more prior to the endometrial biopsy

Locations

Country	Name	City	State
Canada	Obstetrics and Gynecologic Consultants	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Evaluating participants discomfort during the procedure, using a pain scale		1 year	No
Secondary	Success rate of passage of the pipelle		1 year	No
Secondary	Adverse effects from medications		1 year	No
Secondary	Complications of the procedure		1 year	No