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Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy

Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy

Status
Withdrawn
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00953641
Enrollment
0
Registered
2009-08-06
Start date
2011-09-30
Completion date
2012-09-30
Last updated
2012-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Ripening, Endometrial Biopsy, Menorrhagia

Keywords

Vaginal Misoprostol, Cervical ripening, Endometrial biopsy

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.

Interventions

DRUGMisoprostol

Misoprostol 400ug, suspended in a base (Witepsol 15) as a vaginal suppository Single dose 12h or more prior to the procedure

DRUGPlacebo

Witepsol 15 base, vaginal suppository, Single dose, 12h or more prior to the endometrial biopsy

Sponsors

University of Saskatchewan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
35 Years to No maximum
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

Design outcomes

Primary

MeasureTime 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 pipelle1 year

Secondary

MeasureTime frame
Evaluating participants discomfort during the procedure, using a pain scale1 year
Success rate of passage of the pipelle1 year
Adverse effects from medications1 year
Complications of the procedure1 year

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026