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Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy

NCT ID: NCT00953641

Last Updated: 2012-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-09-30

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.

Conditions

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Menorrhagia Endometrial Biopsy Cervical Ripening

Keywords

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Vaginal Misoprostol Cervical ripening Endometrial biopsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pre-Menopausal 1

Pre-Menopausal group, receiving Misoprostol

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

Misoprostol 400ug, suspended in a base (Witepsol 15) as a vaginal suppository Single dose 12h or more prior to the procedure

Pre-Menopausal 2

Patients will insert a placebo vaginal suppository 12h or more prior to the endometrial biopsy

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Witepsol 15 base, vaginal suppository, Single dose, 12h or more prior to the endometrial biopsy

Post-Menopausal 1

Post-Menopausal patients will insert a Misoprostol vaginal suppository 12h or more prior to the endometrial biopsy

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

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 vaginal suppository prior to the endometrial biopsy

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Witepsol 15 base, vaginal suppository, Single dose, 12h or more prior to the endometrial biopsy

Interventions

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Misoprostol

Misoprostol 400ug, suspended in a base (Witepsol 15) as a vaginal suppository Single dose 12h or more prior to the procedure

Intervention Type DRUG

Placebo

Witepsol 15 base, vaginal suppository, Single dose, 12h or more prior to the endometrial biopsy

Intervention Type DRUG

Other Intervention Names

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Cytotec

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
Minimum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Saskatchewan

OTHER

Sponsor Role lead

Responsible Party

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Anita Harding

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roger Pierson, PhD

Role: STUDY_CHAIR

University of Saskatchewan, Dept. of Obstetrics and Gynecology, College of Medicine

Anita Harding, MBChB

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan, Dept. of Obstetrics and Gynecology, College of Medicine

Thirza Smith, MD, FRCS

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan, Dept. of Obstetrics and Gynecology

Marilyn Davidson, FRCSC

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan, Dept. of Obstetrics and Gynecology

Locations

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Obstetrics and Gynecologic Consultants

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

Other Identifiers

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07-134

Identifier Type: -

Identifier Source: org_study_id