Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy
35 Years
N/A
Female
Menorrhagia, Endometrial Biopsy, Cervical Ripening
Trial Information
Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
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
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
Roger Pierson, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Saskatchewan, Dept. of Obstetrics and Gynecology, College of Medicine
Authority:
Canada: Health Canada
Study ID:
07-134
NCT ID:
NCT00953641
Start Date:
September 2011
Completion Date:
September 2012
Related Keywords:
- Menorrhagia
- Endometrial Biopsy
- Cervical Ripening
- Vaginal Misoprostol
- Cervical ripening
- Endometrial biopsy
- Menorrhagia
- Adenoma
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