Abnormal Uterine Bleeding Unrelated to Menstrual Cycle Clinical Trial
Official title:
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.
| Status | Recruiting |
| Enrollment | 52 |
| Est. completion date | June 2013 |
| Est. primary completion date | June 2013 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 35 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Faculty of Medicine Siriraj Hospital Mahidol University | Bangkok |
| Lead Sponsor | Collaborator |
|---|---|
| Mahidol University |
Thailand,
Allen R, O'Brien BM. Uses of misoprostol in obstetrics and gynecology. Rev Obstet Gynecol. 2009 Summer;2(3):159-68. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. Epub 2005 Sep 1. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 1 Year | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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