Clinical trial NCT00953641: Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy
Official title: Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Menorrhagia
Endometrial Biopsy
Cervical Ripening
Keywords: Vaginal Misoprostol
Cervical ripening
Endometrial biopsy
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2009-08-06
Enrollment: 0
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: 1 year
Secondary outcomes:
measure: Evaluating participants discomfort during the procedure, using a pain scale
timeFrame: 1 year
measure: Success rate of passage of the pipelle
timeFrame: 1 year
measure: Adverse effects from medications
timeFrame: 1 year
measure: Complications of the procedure
timeFrame: 1 year
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Obstetrics and Gynecologic Consultants
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan, Dept. of Obstetrics and Gynecology, College of Medicine
name: Roger Pierson, PhD
role: STUDY_CHAIR
affiliation: University of Saskatchewan, Dept. of Obstetrics and Gynecology, College of Medicine
name: Anita Harding, MBChB
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Saskatchewan, Dept. of Obstetrics and Gynecology
name: Thirza Smith, MD, FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Saskatchewan, Dept. of Obstetrics and Gynecology
name: Marilyn Davidson, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: