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

NCT01762319 | Unknown

• 1 other identifier: SIOGMVA002
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Abnormal Uterine Bleeding Unrelated to Menstrual Cycle

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Misoprostol

EXPERIMENTAL

200 mcg Misoprostol SL 1 hour prior to fractional curettage

Drug: Misoprostol

Vitamin B6

PLACEBO COMPARATOR

100 mg Vitamin B6 SL 1 hr prior to fractional curettage

Drug: Vitamin B6

Interventions

Misoprostol DRUG

Also known as: Cytotec

Misoprostol

Vitamin B6 DRUG

Also known as: Besix

Vitamin B6

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• thai women at the age over 35 years old
• presenting with abnormal uterine bleeding and have a plan to perform fractional curettage

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital Mahidol University

Bangkok, 10700, Thailand

RECRUITING

Related Publications (9)

• 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.

  PMID: 21112054 BACKGROUND

• Allen R, O'Brien BM. Uses of misoprostol in obstetrics and gynecology. Rev Obstet Gynecol. 2009 Summer;2(3):159-68.

  PMID: 19826573 BACKGROUND

• 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.

  PMID: 21797959 BACKGROUND

• 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.

  PMID: 12618256 BACKGROUND

• 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.

  PMID: 16139942 BACKGROUND

• 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.

  PMID: 17853158 BACKGROUND

• 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.

  PMID: 21475427 BACKGROUND

• 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.

  PMID: 22619908 BACKGROUND

• 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.

  PMID: 16176522 BACKGROUND

MeSH Terms

Interventions

Misoprostol; Vitamin B 6

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Korakot Sirimai, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Korakot Sirimai, Dr.

CONTACT

(66)81-6140655; ksirimai@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2012
• First Posted: January 7, 2013
• Study Start: November 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 7, 2013

Record last verified: 2012-09

Locations

TH (1)