Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy

Conditions
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Menorrhagia, Endometrial Biopsy, Cervical Ripening

Intervention / Treatment
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* Drug: Misoprostol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pre-Menopausal 1<br>Pre-Menopausal group, receiving Misoprostol | Drug: Misoprostol<br>* Misoprostol 400ug, suspended in a base (Witepsol 15) as a vaginal suppository Single dose 12h or more prior to the procedure<br>* Other names: Cytotec;|
| Placebo Comparator: Pre-Menopausal 2<br>Patients will insert a placebo vaginal suppository 12h or more prior to the endometrial biopsy | Drug: Placebo<br>* Witepsol 15 base, vaginal suppository, Single dose, 12h or more prior to the endometrial biopsy<br>|
| Active Comparator: Post-Menopausal 1<br>Post-Menopausal patients will insert a Misoprostol vaginal suppository 12h or more prior to the endometrial biopsy | Drug: Misoprostol<br>* Misoprostol 400ug, suspended in a base (Witepsol 15) as a vaginal suppository Single dose 12h or more prior to the procedure<br>* Other names: Cytotec;|
| Placebo Comparator: Post-Menopausal 2<br>Placebo vaginal suppository prior to the endometrial biopsy | Drug: Placebo<br>* Witepsol 15 base, vaginal suppository, Single dose, 12h or more prior to the endometrial biopsy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating participants discomfort during the procedure, using a pain scale |  | 1 year | 
| Success rate of passage of the pipelle |  | 1 year | 
| Adverse effects from medications |  | 1 year | 
| Complications of the procedure |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaginal Misoprostol, Cervical ripening, Endometrial biopsy