Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy

Sponsor

University of Saskatchewan (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00953641

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Menorrhagia Endometrial Biopsy Cervical Ripening	Drug: Misoprostol Drug: Placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy

Study Start Date :

Sep 1, 2011

Anticipated Primary Completion Date :

Sep 1, 2012

Anticipated Study Completion Date :

Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Pre-Menopausal 1 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 Other Names: Cytotec
Placebo Comparator: Pre-Menopausal 2 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
Active Comparator: Post-Menopausal 1 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 Other Names: Cytotec
Placebo Comparator: Post-Menopausal 2 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

Outcome Measures

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 [1 year]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Obstetrics and Gynecologic Consultants	Saskatoon	Saskatchewan	Canada	S7K 1N8

Sponsors and Collaborators

University of Saskatchewan

Investigators

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