Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy

Status: Withdrawn
Study State Date: September 2011
Primary Completion Date: Anticipated September 2012
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Phase: Phase 3
Why Stopped:  Principle Investigator retired, Resident moved away

Sponsor(s):
University of Saskatchewan
 
Information By: University of Saskatchewan
Trial Identifier: NCT00953641
Official Title: Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy

Description:  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.

+ Additional Objectives Detail

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.



Accepts Healthy Volunteers?: No
Minimum Age: 35 Years
Maximum Age: N/A
Gender(s): Female
Additional 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

Conditions:
Menorrhagia
Cervical Ripening
Adenoma
Endometrial Biopsy
Interventions:
Drug: Misoprostol
Drug: Placebo
 
Primary Outcome Measures:
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
Time Frame: 1 year
Safety Issue: No

 
Secondary Outcome Measures:
Evaluating participants discomfort during the procedure, using a pain scale
Time Frame: 1 year
Safety Issue: No

Success rate of passage of the pipelle
Time Frame: 1 year
Safety Issue: No

Adverse effects from medications
Time Frame: 1 year
Safety Issue: No

Complications of the procedure
Time Frame: 1 year
Safety Issue: No

 
Patient Groups:
Assigned Interventions:

Pre-Menopausal 1: Active Comparator
Pre-Menopausal group, receiving Misoprostol
Drug: Misoprostol
Misoprostol 400ug, suspended in a base (Witepsol 15) as a vaginal suppository Single dose 12h or more prior to the procedure

 
Pre-Menopausal 2: Placebo Comparator
Patients will insert a placebo vaginal suppository 12h or more prior to the endometrial biopsy
Drug: Placebo
Witepsol 15 base, vaginal suppository, Single dose, 12h or more prior to the endometrial biopsy

 
Post-Menopausal 1: Active Comparator
Post-Menopausal patients will insert a Misoprostol vaginal suppository 12h or more prior to the endometrial biopsy
Drug: Misoprostol
Misoprostol 400ug, suspended in a base (Witepsol 15) as a vaginal suppository Single dose 12h or more prior to the procedure

 
Post-Menopausal 2: Placebo Comparator
Placebo vaginal suppository prior to the endometrial biopsy
Drug: Placebo
Witepsol 15 base, vaginal suppository, Single dose, 12h or more prior to the endometrial biopsy

 


Investigators:
Principal Investigator: Anita Harding, MBChB, University of Saskatchewan, Dept. of Obstetrics and Gynecology, College of Medicine
Principal Investigator: Marilyn Davidson, FRCSC, University of Saskatchewan, Dept. of Obstetrics and Gynecology
Study Chair: Roger Pierson, PhD, University of Saskatchewan, Dept. of Obstetrics and Gynecology, College of Medicine
Principal Investigator: Thirza Smith, MD, FRCS, University of Saskatchewan, Dept. of Obstetrics and Gynecology


Study Locations:
+ Show All 1 Study Locations


Canada
Obstetrics and Gynecologic Consultants 
Saskatoon, Canada

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