Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy

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.

Study Overview

• Status: Withdrawn
• Conditions: Menorrhagia; Cervical Ripening; Endometrial Biopsy
• Intervention / Treatment: Drug: Misoprostol; Drug: Placebo

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 Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7K 1N8
      • Obstetrics and Gynecologic Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 31 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): September 1, 2012
• Study Completion (Anticipated): September 1, 2012

Study Registration Dates

• First Submitted: August 26, 2008
• First Submitted That Met QC Criteria: August 5, 2009
• First Posted (Estimate): August 6, 2009

Study Record Updates

• Last Update Posted (Estimate): August 14, 2012
• Last Update Submitted That Met QC Criteria: August 11, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Cervical ripening; Endometrial biopsy; Vaginal Misoprostol
• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Menstruation Disturbances; Uterine Hemorrhage; Menorrhagia; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: 07-134