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

Study Overview
=================
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.

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

Conditions
-----------------
Abnormal Uterine Bleeding Unrelated to Menstrual Cycle

Intervention / Treatment
-----------------
* Drug: Misoprostol
* Drug: Vitamin B6


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Misoprostol<br>200 mcg Misoprostol SL 1 hour prior to fractional curettage | Drug: Misoprostol<br> <br> * Other names: Cytotec;|
| Placebo Comparator: Vitamin B6<br>100 mg Vitamin B6 SL 1 hr prior to fractional curettage | Drug: Vitamin B6<br> <br> * Other names: Besix;|

What is the study measuring?
-----------------
Primary Outcome Measures

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