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Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy

Primary Purpose

Menorrhagia, Endometrial Biopsy, Cervical Ripening

Status
Withdrawn
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Misoprostol
Placebo
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menorrhagia focused on measuring Vaginal Misoprostol, Cervical ripening, Endometrial biopsy

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Obstetrics and Gynecologic Consultants

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Pre-Menopausal 1

Pre-Menopausal 2

Post-Menopausal 1

Post-Menopausal 2

Arm Description

Pre-Menopausal group, receiving Misoprostol

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

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

Placebo vaginal suppository prior to the endometrial biopsy

Outcomes

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

Secondary Outcome Measures

Evaluating participants discomfort during the procedure, using a pain scale
Success rate of passage of the pipelle
Adverse effects from medications
Complications of the procedure

Full Information

First Posted
August 26, 2008
Last Updated
August 11, 2012
Sponsor
University of Saskatchewan
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1. Study Identification

Unique Protocol Identification Number
NCT00953641
Brief Title
Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy
Official Title
Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Principle Investigator retired, Resident moved away
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
September 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menorrhagia, Endometrial Biopsy, Cervical Ripening
Keywords
Vaginal Misoprostol, Cervical ripening, Endometrial biopsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-Menopausal 1
Arm Type
Active Comparator
Arm Description
Pre-Menopausal group, receiving Misoprostol
Arm Title
Pre-Menopausal 2
Arm Type
Placebo Comparator
Arm Description
Patients will insert a placebo vaginal suppository 12h or more prior to the endometrial biopsy
Arm Title
Post-Menopausal 1
Arm Type
Active Comparator
Arm Description
Post-Menopausal patients will insert a Misoprostol vaginal suppository 12h or more prior to the endometrial biopsy
Arm Title
Post-Menopausal 2
Arm Type
Placebo Comparator
Arm Description
Placebo vaginal suppository prior to the endometrial biopsy
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
Cytotec
Intervention Description
Misoprostol 400ug, suspended in a base (Witepsol 15) as a vaginal suppository Single dose 12h or more prior to the procedure
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Witepsol 15 base, vaginal suppository, Single dose, 12h or more prior to the endometrial biopsy
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Evaluating participants discomfort during the procedure, using a pain scale
Time Frame
1 year
Title
Success rate of passage of the pipelle
Time Frame
1 year
Title
Adverse effects from medications
Time Frame
1 year
Title
Complications of the procedure
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Pierson, PhD
Organizational Affiliation
University of Saskatchewan, Dept. of Obstetrics and Gynecology, College of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anita Harding, MBChB
Organizational Affiliation
University of Saskatchewan, Dept. of Obstetrics and Gynecology, College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thirza Smith, MD, FRCS
Organizational Affiliation
University of Saskatchewan, Dept. of Obstetrics and Gynecology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marilyn Davidson, FRCSC
Organizational Affiliation
University of Saskatchewan, Dept. of Obstetrics and Gynecology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Obstetrics and Gynecologic Consultants
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 1N8
Country
Canada

12. IPD Sharing Statement

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Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy

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