Cervical Ripening Before Endometrial Biopsy in Abnormal Uterine Bleeding Using Sublingual Misoprostol
NCT ID: NCT01762319
Last Updated: 2013-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
52 participants
INTERVENTIONAL
2012-11-30
2013-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Misoprostol
200 mcg Misoprostol SL 1 hour prior to fractional curettage
Misoprostol
Vitamin B6
100 mg Vitamin B6 SL 1 hr prior to fractional curettage
Vitamin B6
Interventions
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Misoprostol
Vitamin B6
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* presenting with abnormal uterine bleeding and have a plan to perform fractional curettage
Exclusion Criteria
* 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
35 Years
FEMALE
No
Sponsors
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Mahidol University
OTHER
Responsible Party
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Principal Investigators
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Korakot Sirimai, MD
Role: PRINCIPAL_INVESTIGATOR
Mahidol University
Locations
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Faculty of Medicine Siriraj Hospital Mahidol University
Bangkok, , Thailand
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Allen R, O'Brien BM. Uses of misoprostol in obstetrics and gynecology. Rev Obstet Gynecol. 2009 Summer;2(3):159-68.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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SIOGMVA002
Identifier Type: -
Identifier Source: org_study_id
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