Abnormal Uterine Bleeding Unrelated to Menstrual CycleNCT01762319
Cervical Ripening Before Endometrial Biopsy in Abnormal Uterine Bleeding Using Sublingual Misoprostol
A study testing Misoprostol and Vitamin B6 in people with Abnormal Uterine Bleeding Unrelated to Menstrual Cycle, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Abnormal Uterine Bleeding Unrelated to Menstrual Cycle
- What is being tested?
- Misoprostol and Vitamin B6
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteThailand
- Study dates
- Nov 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- thai women at the age over 35 years old
- presenting with abnormal uterine bleeding and have a plan to perform fractional curettage
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital Mahidol University
Bangkok, 10700
Korakot Sirimai, Dr., (66)81-6140655, ksirimai@hotmail.com
Korakot Sirimai, Dr.
About this study
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.
Read more
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.
- Being tested
- Misoprostol, Vitamin B6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Cytotec
Vitamin B6Drug
Also called Besix
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol | Experimental | 200 mcg Misoprostol SL 1 hour prior to fractional curettage Receives: Drug: Misoprostol |
| Vitamin B6 | Placebo comparator | 100 mg Vitamin B6 SL 1 hr prior to fractional curettage Receives: Drug: Vitamin B6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startNov 2012
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Abnormal Uterine Bleeding Unrelated to Menstrual CycleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Korakot Sirimai, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762319
- Sponsor's protocol ID
- SIOGMVA002
- Status last verified
- Sep 2012
- First submitted
- 11 Dec 2012
- Last updated
- 7 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21112054Allen R, O'Brien BM. Uses of misoprostol in obstetrics and gynecology. Rev Obstet Gynecol. 2009 Summer;2(3):159-68.
PubMed 19826573Cooper 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.
PubMed 21797959Saxena 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.
PubMed 12618256Saxena 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.
PubMed 16139942Caliskan 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.
PubMed 17853158Saha 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.
PubMed 21475427Boonyarangkul 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.
PubMed 22619908Tansathit 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.
PubMed 16176522
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Ripening Before Endometrial Biopsy in Abnormal Uterine Bleeding (AUB) Using Sublingual Misoprostol 200 Mcg: A Randomized, Double Blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01762319
- Acronym / sponsor ID
- SIOGMVA002
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 7 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol | Experimental | Drug: Misoprostol200 mcg Misoprostol SL 1 hour prior to fractional curettage |
| Vitamin B6 | Placebo comparator | Drug: Vitamin B6100 mg Vitamin B6 SL 1 hr prior to fractional curettage |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- thai women at the age over 35 years old
- presenting with abnormal uterine bleeding and have a plan to perform fractional curettage
Key exclusion criteria (7 listed)
- uterine anomalies
- pregnancy
- pelvic inflammatory disease
- uncontrolled medical or psychological conditions
- known cases of gynecological diseases such as gynecological malignancies, abnormal pap smear
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MisoprostolAlso: Cytotec | Drug | Misoprostol |
| Vitamin B6Also: Besix | Drug | Vitamin B6 |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2013.
- Background: PubMed 21112054Mittal 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.
- Background: PubMed 19826573Allen R, O'Brien BM. Uses of misoprostol in obstetrics and gynecology. Rev Obstet Gynecol. 2009 Summer;2(3):159-68.
- Background: PubMed 21797959Cooper 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.
- Background: PubMed 12618256Saxena 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.
- Background: PubMed 16139942Saxena 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.
- Background: PubMed 17853158Caliskan 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.
- Background: PubMed 21475427Saha 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.
- Background: PubMed 22619908Boonyarangkul 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.
- Background: PubMed 16176522Tansathit 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Korakot Sirimai, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Misoprostol and Vitamin B6 in people with Abnormal Uterine Bleeding Unrelated to Menstrual Cycle, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Korakot Sirimai, Dr. ((66)81-6140655, ksirimai@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of 200 microgram Misoprostol for cervical ripening prior to performing fractional curettage in patients with abnormal uterine bleeding (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01762319, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2013; AzTrials last refreshed its copy on 1 Nov 2026.