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

January 4, 2013 updated by: Mahidol University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Faculty of Medicine Siriraj Hospital Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Misoprostol
200 mcg Misoprostol SL 1 hour prior to fractional curettage
Drug: Misoprostol
Other Names:
  • Cytotec
PLACEBO_COMPARATOR: Vitamin B6
100 mg Vitamin B6 SL 1 hr prior to fractional curettage
Drug: Vitamin B6
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
Time Frame: 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.
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Korakot Sirimai, MD, Mahidol university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ANTICIPATED)

June 1, 2013

Study Completion (ANTICIPATED)

June 1, 2013

Study Registration Dates

First Submitted

December 11, 2012

First Submitted That Met QC Criteria

January 4, 2013

First Posted (ESTIMATE)

January 7, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 7, 2013

Last Update Submitted That Met QC Criteria

January 4, 2013

Last Verified

September 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIOGMVA002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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