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To compare the effectiveness of vaginal dinoprostone with placebo in minimising the pain experienced by postmenopausal patients during diagnostic office 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, fibroids, 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.The most commonly used agent is misoprostol,a synthetic prostaglandin E1 (PGE1) analogue that is frequently administered in off-label use in obstetrics and gynaecology for medical abortion, labor induction, endometrial biopsy, dilatation and curettage, intrauterine device insertion, myomectomy, postpartum haemorrhage, and cervical ripening.In contrast, dinoprostone, a natural PGE2, is mostly used in obstetrics for cervical ripening and the stimulation of uterine contractions to induce labor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dinoprostone arm | Experimental | 1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy. |
|
| placebo | Placebo Comparator | one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dinoprostone 3Mg Vaginal Tablet | Drug | 1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office diagnostic 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 | an expected average of 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of pain | Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10 | 30 minutes after the procedure |
| Operative time |
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Inclusion Criteria:
Exclusion Criteria:
• Nulliparous patients
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| Name | Affiliation | Role |
|---|---|---|
| AHMED SAMY, MD | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Cairo University | Cairo | 11231 | Egypt |
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| ID | Term |
|---|---|
| D015232 | Dinoprostone |
| D014622 | Vaginal Creams, Foams, and Jellies |
| ID | Term |
|---|---|
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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| placebo vaginal tablet | Drug | 1 vaginal tablet of placebo inserted by the patient 12 hours before the scheduled office diagnostic hysteroscopy. |
|
From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination
| an expected average 10 minutes |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D053566 | Feminine Hygiene Products |
| D004864 | Equipment and Supplies |