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To compare the effectiveness of vaginal dinoprostone and vaginal Isonicotinic acid hydrazide in minimizing the pain experienced by postmenopausal patients during diagnostic ofļ¬ce hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopist.
hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as polyps, ļ¬broids, septa, and adhesions, and in the presence of abnormal bleeding and during the removal of an intrauterine device or foreign body. Cervical ripening is made possible by the use of medication through different routes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INH | Experimental | 3 tablet of INH 900 mg inserted by the patient 12 hours before the scheduled office hysteroscopy. |
|
| dinoprostone | Active Comparator | 1 vaginal tablet of dinoprostone (3mg) (prostinĀ® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INH | Drug | 3 tablet of INH inserted by the patient 12 hours before the scheduled office hysteroscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of pain | Pain intensity will be assessed by visual analogue scale during the procedure. Visual analogue scale ranging from 0 to 10 | 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination | 15 minutes |
| Pain intensity will be assessed by visual analogue scale | Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure. Visual analogue scale ranging from 0 to 10 |
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Inclusion Criteria:
Exclusion Criteria:
Menopausal patients with an indication for ofļ¬ce hysteroscopy
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| hany f Sallam, md | Contact | +20102435461 | 002 | hany.farouk@aswu.edu.eg |
| nahla w Shady, md | Contact | +201022336052 | 002 | hanygyne@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| nahla w Shady, md | Aswan universirty | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aswan University Hospital | Recruiting | AswÄn | 81528 | Egypt |
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| ID | Term |
|---|---|
| D007538 | Isoniazid |
| D015232 | Dinoprostone |
| C501608 | KLK15 protein, human |
| ID | Term |
|---|---|
| D006834 | Hydrazines |
| D009930 | Organic Chemicals |
| D007539 | Isonicotinic Acids |
| D000147 | Acids, Heterocyclic |
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open label randomized controlled study
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open label randomized controlled study
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| dinoprostone | Drug | 1 vaginal tablet of dinoprostone (3mg) (prostinĀ® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy. |
|
|
| 30 minutes after the procedure |
| D006571 |
| Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |