Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy
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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 |
- 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 ]
- 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 |
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| Canada, Saskatchewan | |
| Obstetrics and Gynecologic Consultants | |
| Saskatoon, Saskatchewan, Canada, S7K 1N8 | |
| 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 Adenoma Uterine Hemorrhage Uterine Diseases Genital Diseases, Female Menstruation Disturbances Pathologic Processes Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
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 May 21, 2013