Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy

• Evaluating participants discomfort during the procedure, using a pain scale [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• Success rate of passage of the pipelle [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• Adverse effects from medications [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• Complications of the procedure [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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.

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.

• Menorrhagia
• Endometrial Biopsy
• Cervical Ripening

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

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

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