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

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ClinicalTrials.gov Identifier: NCT01762319
Recruitment Status : Unknown
Verified September 2012 by Mahidol University.
Recruitment status was:  Recruiting
First Posted : January 7, 2013
Last Update Posted : January 7, 2013
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Abnormal Uterine Bleeding Unrelated to Menstrual Cycle Drug: Misoprostol Drug: Vitamin B6 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cervical Ripening Before Endometrial Biopsy in Abnormal Uterine Bleeding (AUB) Using Sublingual Misoprostol 200 Mcg: A Randomized, Double Blind, Placebo-controlled Trial
Study Start Date : November 2012
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Misoprostol
200 mcg Misoprostol SL 1 hour prior to fractional curettage
Drug: Misoprostol
Other Name: Cytotec
Placebo Comparator: Vitamin B6
100 mg Vitamin B6 SL 1 hr prior to fractional curettage
Drug: Vitamin B6
Other Name: Besix



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01762319


Contacts
Contact: Korakot Sirimai, Dr. (66)81-6140655 ksirimai@hotmail.com

Locations
Thailand
Faculty of Medicine Siriraj Hospital Mahidol University Recruiting
Bangkok, Thailand, 10700
Contact: Korakot Sirimai, Dr.    (66)81-6140655    ksirimai@hotmail.com   
Principal Investigator: Korakot Sirimai, Dr.         
Sub-Investigator: Tripop Lertbunnaphong, Dr.         
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Korakot Sirimai, MD Mahidol University

Publications:

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01762319     History of Changes
Other Study ID Numbers: SIOGMVA002
First Posted: January 7, 2013    Key Record Dates
Last Update Posted: January 7, 2013
Last Verified: September 2012

Additional relevant MeSH terms:
Hemorrhage
Uterine Hemorrhage
Metrorrhagia
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
Vitamins
Vitamin B 6
Pyridoxal
Pyridoxine
Misoprostol
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics