Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy

This study has been withdrawn prior to enrollment.
(Principle Investigator retired, Resident moved away)
Sponsor:
Information provided by (Responsible Party):
Anita Harding, University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT00953641
First received: August 26, 2008
Last updated: August 11, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Menorrhagia
Endometrial Biopsy
Cervical Ripening
Drug: Misoprostol
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy

Resource links provided by NLM:


Further study details as provided by University of Saskatchewan:

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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluating participants discomfort during the procedure, using a pain scale [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Success rate of passage of the pipelle [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Adverse effects from medications [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Complications of the procedure [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: September 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953641

Locations
Canada, Saskatchewan
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
  More Information

No publications provided

Responsible Party: Anita Harding, Dr., University of Saskatchewan
ClinicalTrials.gov Identifier: NCT00953641     History of Changes
Other Study ID Numbers: 07-134
Study First Received: August 26, 2008
Last Updated: August 11, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of Saskatchewan:
Vaginal Misoprostol
Cervical ripening
Endometrial biopsy

Additional relevant MeSH terms:
Menorrhagia
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes
Misoprostol
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on April 23, 2014