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

Primary Purpose

Abnormal Uterine Bleeding Unrelated to Menstrual Cycle

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Misoprostol
Vitamin B6
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abnormal Uterine Bleeding Unrelated to Menstrual Cycle

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Faculty of Medicine Siriraj Hospital Mahidol UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Misoprostol

Vitamin B6

Arm Description

200 mcg Misoprostol SL 1 hour prior to fractional curettage

100 mg Vitamin B6 SL 1 hr prior to fractional curettage

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 11, 2012
Last Updated
January 4, 2013
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT01762319
Brief Title
Cervical Ripening Before Endometrial Biopsy in Abnormal Uterine Bleeding Using Sublingual Misoprostol
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 Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abnormal Uterine Bleeding Unrelated to Menstrual Cycle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Misoprostol
Arm Type
Experimental
Arm Description
200 mcg Misoprostol SL 1 hour prior to fractional curettage
Arm Title
Vitamin B6
Arm Type
Placebo Comparator
Arm Description
100 mg Vitamin B6 SL 1 hr prior to fractional curettage
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
Cytotec
Intervention Type
Drug
Intervention Name(s)
Vitamin B6
Other Intervention Name(s)
Besix
Primary Outcome Measure Information:
Title
efficacy of 200 microgram Misoprostol for cervical ripening prior to performing fractional curettage in patients with abnormal uterine bleeding
Description
an efficacy of sublingual misoprostol in this study was dilatation of uterine cervix which was measured by a diameter of MVA cannula in millimeters.
Time Frame
1 Year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Korakot Sirimai, Dr.
Phone
(66)81-6140655
Email
ksirimai@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Korakot Sirimai, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Korakot Sirimai, Dr.
Phone
(66)81-6140655
Email
ksirimai@hotmail.com
First Name & Middle Initial & Last Name & Degree
Korakot Sirimai, Dr.
First Name & Middle Initial & Last Name & Degree
Tripop Lertbunnaphong, Dr.

12. IPD Sharing Statement

Citations:
PubMed Identifier
21112054
Citation
Mittal S, Sehgal R, Aggarwal S, Aruna J, Bahadur A, Kumar G. Cervical priming with misoprostol before manual vacuum aspiration versus electric vacuum aspiration for first-trimester surgical abortion. Int J Gynaecol Obstet. 2011 Jan;112(1):34-9. doi: 10.1016/j.ijgo.2010.07.035. Epub 2010 Nov 26.
Results Reference
background
PubMed Identifier
19826573
Citation
Allen R, O'Brien BM. Uses of misoprostol in obstetrics and gynecology. Rev Obstet Gynecol. 2009 Summer;2(3):159-68.
Results Reference
background
PubMed Identifier
21797959
Citation
Cooper NA, Smith P, Khan KS, Clark TJ. Does cervical preparation before outpatient hysteroscopy reduce women's pain experience? A systematic review. BJOG. 2011 Oct;118(11):1292-301. doi: 10.1111/j.1471-0528.2011.03046.x. Epub 2011 Jul 29.
Results Reference
background
PubMed Identifier
12618256
Citation
Saxena P, Salhan S, Sarda N. Role of sublingual misoprostol for cervical ripening prior to vacuum aspiration in first trimester interruption of pregnancy. Contraception. 2003 Mar;67(3):213-7. doi: 10.1016/s0010-7824(02)00517-6.
Results Reference
background
PubMed Identifier
16139942
Citation
Saxena P, Salhan S, Sarda N. Sublingual versus vaginal route of misoprostol for cervical ripening prior to surgical termination of first trimester abortions. Eur J Obstet Gynecol Reprod Biol. 2006 Mar 1;125(1):109-13. doi: 10.1016/j.ejogrb.2005.07.022. Epub 2005 Sep 1.
Results Reference
background
PubMed Identifier
17853158
Citation
Caliskan E, Filiz T, Yucesoy G, Coskun E, Vural B, Corakci A. Sublingual versus vaginal misoprostol for cervical ripening PRIOR TO manual vacuum aspiration under local anaesthesia: a randomized study. Eur J Contracept Reprod Health Care. 2007 Dec;12(4):372-7. doi: 10.1080/13625180701549758.
Results Reference
background
PubMed Identifier
21475427
Citation
Saha SP, Bhattacharjee N, Baru G. Vaginal Misoprostol for Cervical Priming before Gynaecological Procedures on Non Pregnant Women. Int J Health Sci (Qassim). 2007 Jul;1(2):185-93.
Results Reference
background
PubMed Identifier
22619908
Citation
Boonyarangkul A, Leksakulchai O. Comparison of level of pain between using manual vacuum aspiration and sharp curettage in management of abnormal uterine bleeding. J Med Assoc Thai. 2011 Dec;94 Suppl 7:S57-61.
Results Reference
background
PubMed Identifier
16176522
Citation
Tansathit T, Chichareon S, Tocharoenvanich S, Dechsukhum C. Diagnostic evaluation of Karman endometrial aspiration in patients with abnormal uterine bleeding. J Obstet Gynaecol Res. 2005 Oct;31(5):480-5. doi: 10.1111/j.1447-0756.2005.00324.x.
Results Reference
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Cervical Ripening Before Endometrial Biopsy in Abnormal Uterine Bleeding Using Sublingual Misoprostol

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