NCT01762319

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

Cervical Ripening Before Endometrial Biopsy in Abnormal Uterine Bleeding (AUB) Using Sublingual Misoprostol 200 Mcg: A Randomized, Double Blind, Placebo-controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: Female
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Abnormal Uterine Bleeding Unrelated to Menstrual Cycle

Interventions

Type	Name	Description
DRUG	Misoprostol
DRUG	Vitamin B6

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2013-01-07
• Last updated: 2013-01-07

Locations

1 site across 1 country: Thailand