Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy

Last updated: August 11, 2012
Sponsor: University of Saskatchewan
Overall Status: Trial Not Available

Phase

3

Condition

Endometrial Cancer

Menstrual Disorders

Female Hormonal Deficiencies/abnormalities

Treatment

N/A

Clinical Study ID

NCT00953641
07-134
  • Ages > 35
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with abnormal uterine bleeding

  • Age over 35 years

Exclusion

Exclusion Criteria:

  • Pregnancy

  • Allergy to or contraindication to prostaglandin use

  • Active genital tract infections

  • Bleeding disorders

Study Design

Study Start date:
September 01, 2011
Estimated Completion Date:
September 30, 2012

Study 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.

Connect with a study center

  • Obstetrics and Gynecologic Consultants

    Saskatoon, Saskatchewan S7K 1N8
    Canada

    Site Not Available

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