Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy

University of Saskatchewan

Status and phase: Withdrawn; Phase 3

Conditions: Cervical Ripening; Endometrial Biopsy; Menorrhagia

Treatments: Drug: Placebo; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT00953641

07-134

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 4 patient groups, including a placebo group

Pre-Menopausal 1

Active Comparator group

Description:

Pre-Menopausal group, receiving Misoprostol

Treatment:

Drug: Misoprostol

Pre-Menopausal 2

Placebo Comparator group

Description:

Patients will insert a placebo vaginal suppository 12h or more prior to the endometrial biopsy

Treatment:

Drug: Placebo

Post-Menopausal 1

Active Comparator group

Description:

Post-Menopausal patients will insert a Misoprostol vaginal suppository 12h or more prior to the endometrial biopsy

Treatment:

Drug: Misoprostol

Post-Menopausal 2

Placebo Comparator group

Description:

Placebo vaginal suppository prior to the endometrial biopsy

Treatment:

Drug: Placebo