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

Mahidol University

Status: Unknown

Conditions: Abnormal Uterine Bleeding Unrelated to Menstrual Cycle

Treatments: Drug: Vitamin B6; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT01762319

SIOGMVA002

Details and patient eligibility

About

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.

Enrollment: 52 estimated patients

Sex: Female

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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52 participants in 2 patient groups, including a placebo group

Misoprostol

Experimental group

Description:

200 mcg Misoprostol SL 1 hour prior to fractional curettage

Treatment:

Drug: Misoprostol

Vitamin B6

Placebo Comparator group

Description:

100 mg Vitamin B6 SL 1 hr prior to fractional curettage

Treatment:

Drug: Vitamin B6