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Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Hysteroscopy

NCT ID: NCT01718314

Last Updated: 2012-10-31

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-03-31

Brief Summary

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Hysteroscopy is an instrument to visualize the interior walls of uterus (womb) and it enables the doctor to do minor operative procedures. Although it causes little discomfort, sometimes it may be disturbing for the patient. This pain is usually perceived during the passage of the instrument through the cervix (neck of the womb). The investigators would like to minimize this pain by two drugs: Misoprotol and lidocaine

Detailed Description

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Outpatient or office hysteroscopy has become the 'gold standard' for the investigation of the intrauterine abnormalities. This minimal invasive modality provides brilliant and clear visualization of the entire uterine cavity and besides this, by the operative channel, minor procedures may easily be performed in the office setting which is priceless for the gynecologist. However, pain related to the procedure may make the procedure uncomfortable for the patient and the physician. Together with the operative time, hysteroscope diameter is considered as the main factor influencing pain. The pain perceived during hysteroscopy may be reduced by using a smaller diameter hysteroscope or by using anesthesia, which decreases pain perception.

In this prospective, randomized, double blind, placebo controlled study, we aim to compare the effectiveness of sublingual misoprostol versus lidocaine pump spray for pain relief during office hysteroscopy.

Conditions

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Pain During Hysteroscopy

Keywords

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Hysteroscopy Misoprostol Lidocaine Visual analogue score

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sublingual Misoprostol & Lidocaine placebo

Misoprostol 200 µg sublingually single dose and Lidocaine spray placebo

Group Type EXPERIMENTAL

Sublingual Misoprostol

Intervention Type DRUG

Placebo (for Lidocaine)

Intervention Type DRUG

The pharmacy-produced sterile saline containing pump spray external characteristics identical to lidocaine pump spray

Lidocaine Pump Spray & Misoprostol placebo

Lidocaine Pump spray, 6 sprays to cervix (60 mg totally) and sublingual misoprotol placebo

Group Type EXPERIMENTAL

Lidocaine pump spray

Intervention Type DRUG

Placebo (for Misoprostol)

Intervention Type DRUG

Lactose filler, the pharmacy-produced pills identical to original misoprostol pill

Interventions

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Sublingual Misoprostol

Intervention Type DRUG

Lidocaine pump spray

Intervention Type DRUG

Placebo (for Misoprostol)

Lactose filler, the pharmacy-produced pills identical to original misoprostol pill

Intervention Type DRUG

Placebo (for Lidocaine)

The pharmacy-produced sterile saline containing pump spray external characteristics identical to lidocaine pump spray

Intervention Type DRUG

Other Intervention Names

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Cytotec Xylocaine %10 pump spray

Eligibility Criteria

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Inclusion Criteria

* Premenopausal women in the proliferative phase of the menstrual cycle with no contraindication for hysteroscopy

Exclusion Criteria

* vaginal bleeding at the time of the procedure
* known sensitivity to lidocaine (amide group local anesthetics) or prostaglandins
* epilepsy
* significantly impaired respiratory or cardiac conduction functions
* hypertension
* glaucoma
* renal failure
* acute liver disease
* uncontrolled diabetes mellitus
* pregnancy or suspicion of pregnancy
* pelvic inflammatory disease
* cervical operation history
* vaginismus.
Minimum Eligible Age

18 Years

Maximum Eligible Age

51 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Dr. Sami Ulus Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sertac ESIN

Obstetrician and Gynecologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tuncay Kucukozkan, Professor

Role: STUDY_CHAIR

Sami Ulus Maternity and Childrens Hospital

Locations

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Dr Sami Ulus Maternity and Children Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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van Dongen H, de Kroon CD, Jacobi CE, Trimbos JB, Jansen FW. Diagnostic hysteroscopy in abnormal uterine bleeding: a systematic review and meta-analysis. BJOG. 2007 Jun;114(6):664-75. doi: 10.1111/j.1471-0528.2007.01326.x.

Reference Type RESULT
PMID: 17516956 (View on PubMed)

De Iaco P, Marabini A, Stefanetti M, Del Vecchio C, Bovicelli L. Acceptability and pain of outpatient hysteroscopy. J Am Assoc Gynecol Laparosc. 2000 Feb;7(1):71-5. doi: 10.1016/s1074-3804(00)80012-2.

Reference Type RESULT
PMID: 10648742 (View on PubMed)

Mulayim B, Celik NY, Onalan G, Bagis T, Zeyneloglu HB. Sublingual misoprostol for cervical ripening before diagnostic hysteroscopy in premenopausal women: a randomized, double blind, placebo-controlled trial. Fertil Steril. 2010 May 1;93(7):2400-4. doi: 10.1016/j.fertnstert.2009.01.073. Epub 2009 Feb 24.

Reference Type RESULT
PMID: 19243750 (View on PubMed)

Other Identifiers

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HEK 11/33-21

Identifier Type: -

Identifier Source: org_study_id