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This study has been withdrawn prior to enrollment.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

August 26, 2008
August 11, 2012
September 2011
September 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00953641 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Menorrhagia
  • Endometrial Biopsy
  • Cervical Ripening
  • 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
  • Drug: Placebo
    Witepsol 15 base, vaginal suppository, Single dose, 12h or more prior to the endometrial biopsy
  • Active Comparator: Pre-Menopausal 1
    Pre-Menopausal group, receiving Misoprostol
    Intervention: Drug: Misoprostol
  • Placebo Comparator: Pre-Menopausal 2
    Patients will insert a placebo vaginal suppository 12h or more prior to the endometrial biopsy
    Intervention: Drug: Placebo
  • Active Comparator: Post-Menopausal 1
    Post-Menopausal patients will insert a Misoprostol vaginal suppository 12h or more prior to the endometrial biopsy
    Intervention: Drug: Misoprostol
  • Placebo Comparator: Post-Menopausal 2
    Placebo vaginal suppository prior to the endometrial biopsy
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Female
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00953641
07-134
No
Anita Harding, University of Saskatchewan
University of Saskatchewan
Not Provided
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
University of Saskatchewan
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP