Cervical Ripening Before Endometrial Biopsy in Abnormal Uterine Bleeding Using Sublingual Misoprostol

Not Applicable

• Conditions: Abnormal Uterine Bleeding Unrelated to Menstrual Cycle
• Interventions: Drug: Misoprostol; Drug: Vitamin B6

• Registration Number: NCT01762319
• Lead Sponsor: Mahidol University

Brief Summary

Abnormal uterine bleeding is common in Thai women. Fractional curettage is an diagnostic procedure of this condition. Traditionally, fractional curettage is performed under local anesthesia such as paracervical nerve block or intravenous meperidine.

Cervical dilatation using "metal cervical dilator" is a common method prior to perform fractional curettage. However, complication from this procedure can be occurred frequently, for example, uterine perforation, false tract formation and laceration of cervix.

Misoprostol is a prostaglandin E1 analogue which is commonly used in obstetrics and gynecology. Misoprostol transforms cervical component causing cervical ripening. This is very helpful for transcervical procedure because cervical dilatation is usually omitted. It can be prescribed in many route and sublingual route is the most effectiveness. Moreover, WHO supports the use of misoprostol in obstetrics and gynecology practice.

The hypothesis of this study is that "Misoprostol 200 micrograms sublingually is effective for cervical ripening before performing fractional curettage in patients with abnormal uterine bleeding" Double blind randomised controlled trial was performed using 26 patients in each group.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-09
• Study Start: 2012-11
• Study First Submitted: 2012-12-11
• Study First Submitted QC: 2013-01-04
• Last Update Submitted: 2013-01-04
• Study First Posted: 2013-01-07
• Last Update Posted: 2013-01-07
• Primary Completion: 2013-06
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 52

Inclusion Criteria

• thai women at the age over 35 years old
• presenting with abnormal uterine bleeding and have a plan to perform fractional curettage

Exclusion Criteria

• uterine anomalies
• pregnancy
• pelvic inflammatory disease
• uncontrolled medical or psychological conditions
• known cases of gynecological diseases such as gynecological malignancies, abnormal pap smear
• Prostaglandin allergy
• Contraindicate to prostaglandin: asthma, mitral valve stenosis, glaucoma, sickle cell anemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Misoprostol	Misoprostol	200 mcg Misoprostol SL 1 hour prior to fractional curettage
Vitamin B6	Vitamin B6	100 mg Vitamin B6 SL 1 hr prior to fractional curettage

Primary Outcome Measures

Name	Time	Method
efficacy of 200 microgram Misoprostol for cervical ripening prior to performing fractional curettage in patients with abnormal uterine bleeding	1 Year	an efficacy of sublingual misoprostol in this study was dilatation of uterine cervix which was measured by a diameter of MVA cannula in millimeters.

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital Mahidol University; 🇹🇭 Bangkok, Thailand