Vaginal Dinoprostone Versus Isonicotinic Acid Hydrazide Prior to Diagnostic Office Hysteroscopy

Study Overview
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Brief Summary
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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 ofﬁce hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopist.

Detailed Description
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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.

Official Title
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Vaginal Dinoprostone Versus Vaginal Isonicotinic Acid Hydrazide Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients: a Randomized Controlled Trial

Conditions
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Postmenopausal Bleeding

Intervention / Treatment
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* Drug: INH
* Drug: dinoprostone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Menopausal patients with an indication for ofﬁce hysteroscopy (postmenopausal bleeding or abnormal ultrasound ﬁndings) Exclusion Criteria: Nulliparous patients patients with cervical pathology retroverted uterus (detected by transvaginal ultrasound) previous cervical surgery patients with severe vaginal bleeding allergy or contraindications to dinoprostone or INH therapy

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: open label randomized controlled study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INH<br>3 tablet of INH 900 mg inserted by the patient 12 hours before the scheduled office hysteroscopy. | Drug: INH<br>* 3 tablet of INH inserted by the patient 12 hours before the scheduled office hysteroscopy<br>* Other names: Isonicotinic acid hydrazide;|
| Active Comparator: dinoprostone<br>1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy. | Drug: dinoprostone<br>* 1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.<br>* Other names: prostin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 30 minutes after the procedure |