Menorrhagia Clinical Trial
Official title:
Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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